Analysis on Application Approval of New Food Additives in the First Half of 2022 - Regulatory News - Food & Food Contact Materials

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 "衛食添新申字", and there is no distinction between domestic and imported products.

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

No.	Acceptance date	Acceptance Code	Name of New Food Additives
1	2022.01.06	衛食添新申字(2022)第0001號	Carboxypeptidase
2	2022.01.10	衛食添新申字(2022)第0002號	Monascus yellow pigment
3	2022.01.30	衛食添新申字(2022)第0003號	Carmine cochineal
4	2022.02.11	衛食添新申字(2022)第0004號	Rebaudioside A
5	2022.02.11	衛食添新申字(2022)第0005號	Stevia glycosides
6	2022.02.11	衛食添新申字(2022)第0006號	Stevia extract
7	2022.02.16	衛食添新申字(2022)第0007號	Magnesium stearate
8	2022.03.03	衛食添新申字(2022)第0008號	L-alanine
9	2022.03.07	衛食添新申字(2022)第0009號	Xylanase
10	2022.03.07	衛食添新申字(2022)第0010號	Aminopeptidase
11	2022.03.08	衛食添新申字(2022)第0011號	L-leucine
12	2022.03.08	衛食添新申字(2022)第0012號	L-isoleucine
13	2022.03.08	衛食添新申字(2022)第0013號	L-valine
14	2022.03.21	衛食添新申字(2022)第0014號	6S-5-methyltetrahydrofolate calcium
15	2022.04.02	衛食添新申字(2022)第0015號	Maltose alpha-amylase
16	2022-04-26	衛食添新申字(2022)第0016號	Lactase (beta-galactosidase)
17	2022.04.28	衛食添新申字(2022)第0017號	Phospholipase A2
18	2022.05.10	衛食添新申字(2022)第0018號	Serine protease
19	2022.05.10	衛食添新申字(2022)第0019號	Serine protease
20	2022.05.10	衛食添新申字(2022)第0020號	Xylanase
21	2022.05.23	衛食添新申字(2022)第0021號	2-hexyl pyridine
22	2022.05.26	衛食添新申字(2022)第0022號	L-cystine
23	2022.05.26	衛食添新申字(2022)第0023號	L-cysteine hydrochloride monohydrate
24	2022.05.26	衛食添新申字(2022)第0024號	L-lysine acetate
25	2022.05.26	衛食添新申字(2022)第0025號	L-histidine
26	2022.05.26	衛食添新申字(2022)第0026號	L-threonine
27	2022.05.26	衛食添新申字(2022)第0027號	L-cysteine hydrochloride
28	2022.05.26	衛食添新申字(2022)第0028號	L-cysteine
29	2022.05.26	衛食添新申字(2022)第0029號	L-phenylalanine
30	2022.05.26	衛食添新申字(2022)第0030號	L-lysine hydrochloride
31	2022.05.26	衛食添新申字(2022)第0031號	L- histidine hydrochloride monohydrate
32	2022.05.27	衛食添新申字(2022)第0032號	Pyrrolidino -[1,2e] -4h-2,4-dimethyl-1,3,5-dithiazide
33	2022.06.02	衛食添新申字(2022)第0033號	D-psicose 3-epimerase
34	2022.06.09	衛食添新申字(2022)第0034號	Rock mineral selenium
35	2022.06.13	衛食添新申字(2022)第0035號	L-selenomethyl selenocysteine
36	2022.06.13	衛食添新申字(2022)第0036號	Ammonium glycyrrhizinate
37	2022.06.13	衛食添新申字(2022)第0037號	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: 衛食添新申字(2021)第0040號; 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: 衛食添新申字(2021)第0039號; 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: 衛食添新申字(2021)第0041號; 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: 衛食添新申字(2021)第0053號; 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)

Name

Function

Food name/category

Maximum level (g/kg)

Approval Status

(By the end of June 2022)

Sodium sulfide pentahydrate

Deacidizing agent, decolorizing agent, settling agent

Salt production process

0.065

Accepted on July 7, 2021, Acceptance number: 衛食添新申字(2021)第0030號;

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: 衛食添新申字(2021)第0048號; and accepted on November 3, 2021, Acceptance number: 衛食添新申字(2021)第0050號, 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)

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(By the end of June 2022)

Acesulfame potassium

Sweetener

07.03

Crackers

0.6

Accepted on June 4, 2021, Acceptance number: 衛食添新申字(2021)第0022號;

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.

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: 衛食添新申字(2022)第0003號;

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: 衛食添新申字(2021)第0013號; 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:衛食添新申字(2021)第0014號; 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: 衛食添新申字(2020)第0068號; 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: 衛食添新申字(2021)第0015號; 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: 衛食添新申字(2020)第0027號; 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: 衛食添新申字(2021)第0040號; 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: 衛食添新申字(2021)第0039號; 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: 衛食添新申字(2021)第0041號; 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: 衛食添新申字(2021)第0027號; 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: 衛食添新申字(2021)第0052號; 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:衛食添新申字(2021)第0016號; 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: 衛食添新申字(2020)第0047號; 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)

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Acceptance information, public comment and approval announcements

(By the end of June 2022)

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: 衛食添新申字(2021)第0020號;

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)

Name

Function

Usage scope

Maximum level (g/kg)

Acceptance information, public comment and approval announcements

(By the end of June 2022)

Sodium sulfide pentahydrate

Deacidifying agent, decolorizing agent, settling agent

Salt production process

0.065

Accepted on July 7, 2021, Acceptance number: 衛食添新申字(2021)第0030號;

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: 衛食添新申字(2021)第0033號; 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: 衛食添新申字(2021)第0019號; 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:衛食添新申字(2021)第0025號; 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: 衛食添新申字(2021)第0018號; 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: 衛食添新申字(2021)第0024號; 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: 衛食添新申字(2021)第0017號; 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: 衛食添新申字(2021)第0012號; 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	04.01.02.05	Jam	5.0
7	Glutamine transaminase	Stabilizer and coagulant	01.02.02	Flavored fermented milk	0.3	Accepted on January 20, 2021, Acceptance number: 衛食添新申字(2021)第0005號; 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.
7	Glutamine transaminase	Stabilizer and coagulant	01.06.01	Unripened cheese	0.3
8	Magnesium chloride	Flavoring agent	06.07	Instant rice and flour products	Appropriate level	Accepted on September 11, 2020, Acceptance number: 衛食添新申字(2020)第0057號; 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: 衛食添新申字(2021)第0043號; 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: 衛食添新申字(2021)第0026號; 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.
10	Lutein	Colorant	01.02.02	Flavoured fermented milk	0.05
11	Acesulfame potassium	Sweetener	07.03	Crackers	0.6	Accepted on June 4, 2021, Acceptance number: 衛食添新申字(2021)第0022號; 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: 衛食添新申字(2020)第0070號; 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: 衛食添新申字(2020)第0039號; 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: 衛食添新申字(2021)第0054號; 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