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

As of the end of June 2021, the National Health Commission of the People's Republic of China (NHC) issued three announcements (No.9, 2020; No.2, 2021; No.5, 2021) by the form of “Three New Food” with a total of 37 products approved including new food raw materials (novel food), new food additives, and food-related products (new food contact substances). Among them, 17 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 2021, a total of 25 new food additives applications were accepted, and 22 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 2021 as following.

1. Name list of new food additives accepted in the first half of 2021 (25 types)

In the first half of 2021, a total of 25 new food additives (including expanded use) applications were accepted by NHC. The acceptance numbers are all "卫食添新申字", and there is no distinction between domestic and imported products.

Among them, Beta-glucanase (卫食添新申字(2021)第0003号) and Vegetable carbon black (卫食添新申字(2021)第0006号) accepted the decision of not granting the administrative license on 13 April, 2021, Potassium sorbate (卫食添新申字(2021)第0011号) accepted decision of not granting administrative license on 18 June,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

2020-01-11

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

Capsicum oleoresin/ Chili oleoresin

9

2021-03-03

卫食添新申字(2021)第0009号

Capsanthin/Chili Red

10

2021-03-03

卫食添新申字(2021)第0010号

Capsanthin/Chili 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

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

Curcumin

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

2. Name list of new food additives passed the technical review and were issued for public comments in the first half of 2021 (22 types)

In the first half of 2021, 22 new food additives passed the technical review of CFSA and were issued for public comments. These include 12 new food enzymes, 1 new food flavouring, 8 existing food additives with expanded use and 1 existing food processing aid with expanded use. In addition to a few additives that are newly accepted in 2021 (such as glutaminase), most of the products which were issued for public comments have been publicly accepted by NHC in 2020. (Refer to Analysis on Application Approval of New food Additives in 2020).

1) Name list of new food enzymes (12 types)

No

Name

Source

Donor

Approval Status

(By the end of June 2021)

1

4-α-glucanotransferase

Aeribacillus pallidus

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

11

Glutaminase

Bacillus licheniformis

Bacillus licheniformis

12

Xylanase

Trichoderma reesei

Aspergillus niger var. tubingensis

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

2) Name list of new food flavouring (1 type)

No

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(By the end of June 2021)

1

Thaumatin

Flavours prepared for food

Formulated into food flavors for all types of food (except food category in Table B.1 of GB 2760-2014)

Appropriate level as required in production

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

3) Name list of food additives with expanded scope (8 types)

No

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(By the end of June 2021)

1

Sucralose

Sweetener

08.03.01

Sauced meat products

0.35

Passed the technical review and issued for public comments on 18th Feb., 2021

2

Advantame

Sweetener

14.04

Carbonated drinks

0.006

Passed the technical review and issued for public comments on 12th Apr.,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

Capsanthin/ Chili 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

Capsanthin/

Chili Red

Colorant

16.07

Other (only for Konjac gel processing)

Appropriate level as required in production

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

8

Capsicum/

Chili oleoresin

Flavor enhancer, colorant

16.07

Other (only for Konjac gel processing)

Appropriate level as required in production

4) Name list of processing aids with expanded scope (1 type)

No

Name

Function

Usage scope

Approval Status

(By the end of June 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 for public comments on 28th May, 2021

3. Name list of approved new food additives in the first half of 2021(17 types)

In the first half of 2021, 17 types of new food additives were approved by NHC, which include 6 new food enzymes for food industry, 1 new food nutrition enhancers, 1 new processing aids, 6 existing food additives with expanded scope, 1 existing food nutrition enhancers with expanded scope, and 2 existing processing aids with expanded scope. CIRS has summarized relevant information below:

1) Name list of approved new food enzymes (6 types)

No

Name

Source

Donor

Acceptance information, public comment and approval announcements

(By the end of June 2021)

1

Beta-amylase

Bacillus licheniformis

Bacillus flexus

Accepted on 12th March, 2020, Acceptance number: 卫食添新申字(2020)第0006号;

Passed the technical review and issued for public comments on 13th Jul., 2020;

7th January, 2021, officially approved by Announcement No.9 of 2020.

2

Alpha-amylase

Bacillus licheniformis

Cytophaga sp.

No accepted information was found;

Passed the technical review and issued for public comments on 27th Sept., 2020;

20th February, 2021, officially approved by Announcement No.2 of 2021.

3

Protease

Bacillus subtilis

Thermus Aquaticus

No accepted information was found;

Passed the technical review and issued for public comments on 12th Nov., 2020;

20th February, 2021, officially approved by Announcement No.2 of 2021.

4

Lactase

Bacillus subtilis

Bifidobacterium bifidum

Accepted on 26th May, 2020, Acceptance number: 卫食添新申字(2020)第0026号;

Passed the technical review and issued for public comments on 27th Sept., 2020;

20th February, 2021, officially approved by Announcement No.2 of 2021.

5

Protease

Bacillus subtilis

Bacillus amyloliquefaciens

No accepted information was found;

Passed the technical review and issued for public comments on 25th Dec., 2020;

25th April, 2021, officially approved by Announcement No.5 of 2021.

6

Phosphoinositide phospholipase C

Pseudomonas fluorescens

Microorganisms encoding the phosphoinositolipase C gene isolated from soil

Accepted on 21st July, 2020, Acceptance number: 卫食添新申字(2020)第0042号;

Passed the technical review and issued for public comments on 25th Dec., 2020;

25th April, 2021, officially approved by Announcement No.5 of 2021.

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

2) Name list of approved new food nutrition enhancers (1 type)

No

Name

Category number

Food Name/ category

Maximum level (g/kg)

Acceptance information, public comment and approval announcements

(By the end of June 2021)

1

vitamin K2

(Synthetic method)

01.03.02

Modified milk powder(limited to milk powder for children)

420 μg/kg–750 μg/kg

No accepted information was found;

Passed the technical review and issued for public comments on 1st Jun.,2020;

7th January, 2021, officially approved by Announcement No.9 of 2020.

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

340 μg/kg–680 μg/kg

3) Name list of approved new processing aid (1 type)

No

Name

Function

Usage scope

Acceptance information, public comment and approval announcements

(By the end of June 2021)

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)

Accepted on 8th April, 2019, Acceptance number: 卫食添新申字(2019)第0031号;

Passed the technical review and issued for public comments on 1st Jun., 2020;

7th January, 2021, officially approved by Announcement No.9 of 2020.

4) Name list of approved food additives with expanded scope (6 types)

No

Name

Function

Category number

Food Name/ category

Maximum level (g/kg)

Note

Acceptance information, public comment and approval announcements

(By the end of June 2021)

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

Accepted on 11th May, 2018, Acceptance number: 卫食添新申字(2018)第0011号;

Passed the technical review and issued for public comments on 13th Jul., 2020;

7th January, 2021, officially approved by Announcement No.9 of 2020.

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

Accepted on 20th January,2020, Acceptance number: 卫食添新申字(2020)第0005号;

Passed the technical review and issued for public comments on 1st Jun., 2020, 27th Sept., 2020;

7th January, 2021, officially approved by Announcement No.9 of 2020.

Appropriate level as required in production

Products

suitable for people aged 37 months to 10 years old

3

Silicon dioxide

Anti-caking agentt

04.04.03

Other soy products

(only for bean curd powder)

15.0

Accepted on 30th April,2020, Acceptance number: 卫食添新申字(2020)第0018号;

Passed the technical review and issued for public comments on 27th Sept., 2020;

20th Feb., 2021, officially approved by Announcement No.2 of 2021.

4

Tomato red

Colorant

05.02.02

Other candy except for Gum-based candy

0.25

Accepted on 5th August,2020, Acceptance number: 卫食添新申字(2020)第0044号;

Passed the technical review and issued for public comments on 12th Nov., 2020;

20th Feb., 2021, officially approved by Announcement No.2 of 2021.

12.10.02

Semi-solid blended condiment

0.125

5

Curdlan

Thickener

04.01.02.05

Jam

Appropriate level as required in production

(Note: the approval announcement of this substance is a collection of two applications)

A total of two acceptances, accepted on 17th Aug.,2020, 23rd Oct. 2020, acceptance numbers are respective: 卫食添新申字(2020)第0046号,卫食添新申字(2020)第0060号;

Passed the technical review and issued for public comments on 27th Sept.,2020 and 12th Nov., 2020;

20th February, 2021, officially approved by Announcement No.2 of 2021.

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

No accepted information was found;

Passed the technical review and issued for public comments on 27th Sept., 2020;

20th Feb., 2021, officially approved by Announcement No.2 of 2021.

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

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

No

Name

Category number

Food Name/ category

Maximum level (g/kg)

Acceptance information, public comment and approval announcements

(By the end of June 2021)

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 of GB 31601-2015 and GB24154-2015

No accepted information was found;

Passed the technical review and issued for public comments on 27th Sept., 2020;

20th Feb., 2021, officially approved by Announcement No.2 of 2021.

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

No

Name

Function

Usage scope

Acceptance information, public comment and approval announcements

(By the end of June 2021)

1

Butane

propellant

Processing technology of spray release oil for bakery food

Accepted on 6th August,2020, Acceptance number: 卫食添新申字(2020)第0045号;

Passed the technical review and issued for public comments on 12th Nov., 2020;

20th Feb., 2021, officially approved by Announcement No.2 of 2021.

2

Phosphoric acid(wet-process)

Nutrients for refining, degumming and fermentation

Oil processing technology, fermentation technology

Accepted on 16th Jun.,2020, Acceptance number:卫食添新申字(2020)第0032号,卫食添新申字(2020)第0033号;

Passed the technical review and issued for public comments on 12th Nov., 2020;

20th Feb., 2021, officially approved by Announcement No.2 of 2021.

Based on the analysis on the application approval of new food additives in the first half of 2021, it can be seen that there are a large number of new enzymatic products (35.3% of 17 approved products and 54.5% of 22 products issued the public comments). At the same time, nitrous oxide, the only new type of food processing aids, was approved in this year (a total of 17 have been approved since 2015, and the rest 16 products are for expanded scope).

There are three main stages of applying for a new food additive:

  1. NHC accepts the application.
  2. CFSA runs a technical review and issue public comments.
  3. If everything goes well, NHC will approve the application.

Generally, it will take approximately 1 year to apply for a new food additive. But when it comes to the application for expanding usage scope, the timeline may be shortened. CIRS warmly suggested that related enterprises should get well-prepared before the application to make sure that the products could pass the technical review successfully and get approved.

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