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As of the end of December 2023, the National Health Commission of the People’s Republic of China (NHC) issued five announcements (No. 1 of 2023, No. 3 of 2023, No. 5 of 2023, No. 8 of 2023, and No. 10 of 2023) regarding “Three New Foods”. A total of 74 products have been approved, 33 of which are new food additives, including those with expanded scope.

Analysis on the Application and Approval of New Food Raw Materials (Novel Food) in 2023

CIRS Group has summarized the acceptance and approval status of new food additives in China in 2023 as follows:

Overview of new food additives accepted, issued for public comments and approved in 2023

In 2023, NHC accepted the application of 82 new food additives, including both new types and those with expanded use and scope. The China National Center for Food Safety Risk Assessment (CFSA) issued a total of 22 new food additives for public comment; moreover, HNC approved 33 new food additives, including the ones with expanded scope.

China,Food,Additive,Registration,Application

Figure 1. Overview of new food additives application in 2023

New food additives accepted by NHC in 2023 (82 types)

In 2023, NHC accepted a total of 82 new food additives, including those with expanded scope, with the acceptance codes of both domestic and imported products starting with “衛食添新申字”. Detailed information is shown in the Table below:

No.	Acceptance date	Acceptance code	Name of new food additives
1	2023.01.03	衛食添新申字(2023)第0001號	Phosphoric acid (Wet process)
2	2023.01.05	衛食添新申字(2023)第0002號	Calcium lactate
3	2023.01.05	衛食添新申字(2023)第0003號	2’-fucosyllactose, 2’-FL
4	2023.01.10	衛食添新申字(2023)第0004號	Calcium chloride
5	2023.01.10	衛食添新申字(2023)第0005號	Sodium metabisulphite
6	2023.01.10	衛食添新申字(2023)第0006號	Benzoic acid, sodium benzoate
7	2023.01.10	衛食添新申字(2023)第0007號	Sorbic acid, potassium sorbate
8	2023.01.10	衛食添新申字(2023)第0008號	Ascorbic acid
9	2023.01.10	衛食添新申字(2023)第0009號	Paprika red
10	2023.01.10	衛食添新申字(2023)第0010號	Lactic acid
11	2023.01.10	衛食添新申字(2023)第0011號	Acesulfame potassium
12	2023.01.10	衛食添新申字(2023)第0012號	Paprika oleoresin
13	2023.01.10	衛食添新申字(2023)第0013號	Sucralose
14	2023.01.10	衛食添新申字(2023)第0014號	Tartrazine
15	2023.01.10	衛食添新申字(2023)第0015號	D-isoascorbic acid (erythorbic acid) , sodium D-isoascorbate
16	2023.01.10	衛食添新申字(2023)第0016號	Disodium 5'-ribonucleotide
17	2023.01.10	衛食添新申字(2023)第0017號	Citric acid
18	2023.01.10	衛食添新申字(2023)第0018號	Dehydroacetic acid, sodium dehydroacetate
19	2023.01.10	衛食添新申字(2023)第0019號	Disodium ethylene-diamine-tetra-acetate
20	2023.01.10	衛食添新申字(2023)第0020號	Hydroxytyrosol
21	2023.01.12	衛食添新申字(2023)第0021號	Nitrous oxide
22	2023.01.28	衛食添新申字(2023)第0022號	NMN (β-Nicotinamide mononucleotide)
23	2023.01.29	衛食添新申字(2023)第0023號	Propylene glycol alginate
24	2023.02.02	衛食添新申字(2023)第0024號	D-3-hydroxybutyric acid
25	2023.02.17	衛食添新申字(2023)第0025號	Runmai improver
26	2023.02.27	衛食添新申字(2023)第0026號	Carmine cochineal
27	2023.03.03	衛食添新申字(2023)第0027號	Vitamin K2 (synthesis method)
28	2023.03.03	衛食添新申字(2023)第0028號	Cyclomaltodextin glucanotransferase
29	2023.03.06	衛食添新申字(2023)第0029號	Edible tannin
30	2023.03.06	衛食添新申字(2023)第0030號	Rebaudioside M
31	2023.03.30	衛食添新申字(2023)第0031號	Corderan gum
32	2023.04.23	衛食添新申字(2023)第0032號	D-psicose 3-epimerase
33	2023.05.04	衛食添新申字(2023)第0033號	6’-sialyllactose sodium salt, 6’-SL
34	2023.05.10	衛食添新申字(2023)第0034號	Rebaudioside M
35	2023.05.22	衛食添新申字(2023)第0035號	Xylanase
36	2023.05.25	衛食添新申字(2023)第0036號	Sodium sulfide pentahydrate
37	2023.05.31	衛食添新申字(2023)第0037號	Propylene glycol alginate
38	2023.06.02	衛食添新申字(2023)第0038號	Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate)
39	2023.07.03	衛食添新申字(2023)第0039號	L-alanine
40	2023.07.04	衛食添新申字(2023)第0040號	Ramie Leaf Extract
41	2023.07.04	衛食添新申字(2023)第0041號	Stevia glycoside
42	2023.07.05	衛食添新申字(2023)第0042號	Tetrapotassium pyrophosphate
43	2023.07.06	衛食添新申字(2023)第0043號	Sucralose
44	2023.07.13	衛食添新申字(2023)第0044號	Nitric acid
45	2023.07.14	衛食添新申字(2023)第0045號	2’-fucosyllactose, 2’-FL
46	2023.07.17	衛食添新申字(2023)第0046號	6’-Sialyllactose sodium salt, 6’-SL
47	2023.07.17	衛食添新申字(2023)第0047號	3’-Sialyllactose sodium salt, 3’-SL
48	2023.08.01	衛食添新申字(2023)第0048號	Potassium sorbate
49	2023.08.11	衛食添新申字(2023)第0049號	Polyoxyethylene (20) sorbitan monooleat
50	2023.09.04	衛食添新申字(2023)第0050號	Lycopene
51	2023.09.06	衛食添新申字(2023)第0051號	(6S)-5-methyltetrahydrofolic acid, glucosamine salt
52	2023.09.06	衛食添新申字(2023)第0052號	Butylated hydroxytoluene (BHT)
53	2023.09.07	衛食添新申字(2023)第0053號	Rosemary extract
54	2023.09.15	衛食添新申字(2023)第0054號	Hydroxytyrosol
55	2023.09.18	衛食添新申字(2023)第0055號	Sanzan Gum
56	2023.09.18	衛食添新申字(2023)第0056號	Sanzan Gum
57	2023.09.18	衛食添新申字(2023)第0057號	Lactase (beta-galactosidase)
58	2023.09.19	衛食添新申字(2023)第0058號	2’-fucosyllactose, 2’-FL
59	2023.09.20	衛食添新申字(2023)第0059號	2’-fucosyllactose, 2’-FL
60	2023.09.20	衛食添新申字(2023)第0060號	Nitrous oxide
61	2023.09.20	衛食添新申字(2023)第0061號	2’-fucosyllactose, 2’-FL
62	2023.09.21	衛食添新申字(2023)第0062號	3’-Sialyllactose sodium salt, 3’-SL
63	2023.09.22	衛食添新申字(2023)第0063號	Phosphodiesterase I
64	2023.11.01	衛食添新申字(2023)第0064號	2’-fucosyllactose, 2’-FL
65	2023.11.01	衛食添新申字(2023)第0065號	2’-fucosyllactose, 2’-FL
66	2023.11.03	衛食添新申字(2023)第0066號	Glucoamylase
67	2023.11.03	衛食添新申字(2023)第0067號	Serine protease
68	2023.11.06	衛食添新申字(2023)第0068號	Tripotassium citrate
69	2023.11.08	衛食添新申字(2023)第0069號	Ascorbyl palmitate (enzymatic)
70	2023.11.13	衛食添新申字(2023)第0070號	Zinc sulfate
71	2023.11.20	衛食添新申字(2023)第0071號	Lactase (beta-galactosidase)
72	2023.11.20	衛食添新申字(2023)第0072號	Lipase
73	2023.11.20	衛食添新申字(2023)第0073號	Calcium carbonate (seaweed source)
74	2023.11.21	衛食添新申字(2023)第0074號	3-fucosyllactose, 3-FL
75	2023.11.21	衛食添新申字(2023)第0075號	Sodium sulfide pentahydrate
76	2023.11.30	衛食添新申字(2023)第0076號	2’-fucosyllactose, 2’-FL
77	2023.11.30	衛食添新申字(2023)第0077號	Cellulose
78	2023.12.08	衛食添新申字(2023)第0078號	Sanzan Gum
79	2023.12.11	衛食添新申字(2023)第0079號	Selenium-enriched yeast
80	2023.12.25	衛食添新申字(2023)第0080號	Pomelone [(8E) -undecan-6,8, 10-triene-3-ketone]
81	2023.12.25	衛食添新申字(2023)第0081號	(E)-6-Octenal
82	2023.12.29	衛食添新申字(2023)第0082號	Sanzan Gum

Note: Substances in blue have been issued a rejection decision.

New food additives that have passed the technical review and were issued for public comments in 2023 (22 types)

As of the end of December 2023, 22 new food additives have passed the technical review by the review committee of China CFSA and were issued for public comments, including 6 new food enzymes, 2 new food additives, 1 new nutrition enhancer, 10 food additives with expanded use and 3 food processing aids with expanded use.

(1) New food enzymes issued for public comments (6 types)

S.N.	Name	Source	Donor	Approval status (As of the end of December 2023)
1	Beta-amylase	Bacillus flexus	—	1) Accepted on July 7, 2023. Acceptance code: 衛食添新申字(2021)第0029號; 2) Issued for public comments on February 10 , 2023; 3) Officially approved on August 1, 2023 according to Notice No. 5 of 2023.
2	Lysophospholipase (lecithinase B)	Trichoderma reesei	Aspergillus nishimurae	1) Accepted on July 15, 2022. Acceptance code: 衛食添新申字(2022)第0063號; 2) Issued for public comments on February 10 , 2023; 3) Officially approved on August 1, 2023 according to Notice No. 5 of 2023.
3	Serine protease	Bacillus licheniformis	Nocardiopsis prasina	1) Accepted on May 10, 2022. Acceptance code: 衛食添新申字(2022)第0018號; 2) Issued for public comments on April 24 , 2023; 3) Officially approved on October 7, 2023 according to Notice No. 8 of 2023.
4	Cyclomaltodextin glucanotransferase	Anoxybacillus caldiproteolyticus	—	1) Accepted on March 3, 2023. Acceptance code: 衛食添新申字(2023)第0028號; 2) Issued for public comments on October 26, 2023; 3) It has not been officially approved yet.
5	Cellulase	Penicillium oxalicum	—	1) Accepted on September 14, 2022. Acceptance code: 衛食添新申字(2022)第0072號; 2) Issued for public comments on October 26, 2023; 3) It has not been officially approved yet.
6	D-psicose 3-epimerase	Bacillus subtilis	Clostridium scindens ATCC35704	1) Accepted on April 23, 2023. Acceptance code: 衛食添新申字(2023)第0032號; 2) Issued for public comments on December 29, 2023; 3) It has not been officially approved yet.

(2) New food additives issued for public comments (2 types)

S.N.	Name	Function	Category number	Food name/ category	Maximum levels (g/kg)	Approval status (As of the end of December 2023)
1	Mixed tocotrienol concentrate	Antioxidant	02.01.01	Vegetable oils and fats	0.2 (counted as the total amount of tocopherol and tocotrienol)	1) Accepted on June 21, 2019. Acceptance code: 衛食添新申字(2019)第0037號; 2) Issued for public comments on June 26, 2023; 3) It has not been officially approved.
2	Rebaudioside M	Sweetener	01.01.03	Modified milk	0.18 (count as steviols)	1) Accepted on May 10, 2023. Acceptance code: 衛食添新申字(2023)第0034號; 2) Issued for public comments on October 26, 2023; 3) It has not been officially approved yet.
			01.02.02	Flavored fermented milk	0.2 (count as steviols)
			03.01	Ice cream and iced milk	0.5 (count as steviols)
			05.02.01	Gum-based candy	3.5 (count as steviols)
			14.0	Beverages (except 14.01 packaged drinking water)	0.2 (count as steviols; count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.)

(3) New nutrition enhancers issued for public comments (1 type)

No.	Name	Applicable scope	Maximum levels	Production strain information	Approval status (By the end of December 2023)
1	2’-fucosyllactose	01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose	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), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose, and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).	Source: E. coli BL21(DE3); Donor: Neisseria spp.	1) Accepted on January 5, 2023. Acceptance code: 衛食添新申字(2023)第0003號; 2) Issued for public comments on February 10, 2023; 3) Officially approved on October 7, 2023 according to Notice No. 8 of 2023.
Source: Corynebacterium glutamate ATCC 13032; Donor: Pseudopedobacter saltans	1) Accepted on July 14, 2023. Acceptance code: 衛食添新申字(2023)第0045號; 2) Issued for public comments on August 23, 2023; 3) It has not been officially approved yet.
Source: Escherichia coli BL21(DE3); Donor: Helicobacter pylori	1) Accepted on September 20, 2023. Acceptance code: 衛食添新申字(2023)第0061號; 2) Issued for public comments on October 26, 2023; 3) It has not been officially approved yet.

No.

Name

Applicable scope

Maximum levels

Production strain information

Approval status

(By the end of December 2023)

2’-fucosyllactose

01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose

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), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose, and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).

Source: E. coli BL21(DE3);

Donor: Neisseria spp.

1) Accepted on January 5, 2023. Acceptance code: 衛食添新申字(2023)第0003號;

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

3) Officially approved on October 7, 2023 according to Notice No. 8 of 2023.

Source: Corynebacterium glutamate ATCC 13032;

Donor: Pseudopedobacter saltans

1) Accepted on July 14, 2023. Acceptance code: 衛食添新申字(2023)第0045號;

2) Issued for public comments on August 23, 2023;

3) It has not been officially approved yet.

Source: Escherichia coli BL21(DE3);

Donor: Helicobacter pylori

1) Accepted on September 20, 2023. Acceptance code: 衛食添新申字(2023)第0061號;

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

3) It has not been officially approved yet.

(4) Food additives with expanded scope issued for public comments (10 types)

S.N.	Name	Function	Category number	Food name/ category	Maximum levels (g/kg)	Remarks	Approval status (By the end of December 2023)
1	Calcium lactate	Stabilizer, coagulant, and acidity regulator	04.02.02.03	Pickled vegetables	10.0	-	1) Accepted on January 5, 2023. Acceptance code: 衛食添新申字(2023)第0002號; 2) Issued for public comments on April 24 , 2023; 3) Officially approved on October 7, 2023 according to Notice No. 8 of 2023.
1	Calcium lactate	Stabilizer, coagulant, and acidity regulator	04.02.02.04	Canned vegetables	3.0	-
2	Sanzan Gum	Thickener, stabilizer and coagulant	01.01.03	Modified milk	0.5	-	1) No acceptance information was found; 2) Issued for public comments on February 10 , 2023; 3) Officially approved on October 7, 2023 according to Notice No. 8 of 2023.
			03.01	Ice cream and iced 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
			01.01.03	Modified milk	0.5	-	1) No acceptance information was found; 2) Issued for public comments on April 24 , 2023; 3) Officially approved on October 7, 2023 according to Notice No. 8 of 2023.
			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
3	L-alanine	Flavor enhancer	14.02.03	Fruit and vegetable juice (pulp) drinks	6.0	Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.	1) Accepted on July 3, 2023. Acceptance code:衛食添新申字(2023)第0039號; 2) Issued for public comments on August 23, 2023; 3) It has not been officially approved yet.
4	Propylene glycol alginate	Thickener	06.05.02.01	Bean vermicelli, bean noodles	1.5	-	1) Accepted on May 31, 2023. Acceptance code: 衛食添新申字(2023)第0037號; 2) Issued for public comments on August 23, 2023; 3) It has not been officially approved yet.
4	Propylene glycol alginate	Thickener	06.05.02.04	Round rice ball	1.5	-
5	Lycopene	Colorant	08.02.01	Seasoned meat products (adding seasonings to fresh meats)	0.12	Count as lycopene	1) Accepted on September 4, 2023. Acceptance code: 衛食添新申字(2023)第0050號; 2) Issued for public comments on October 26, 2023; 3) It has not been officially approved yet.
			08.02.02	Cured meat products (e.g., salt meats, cured meats, dried salted duck, Chinese ham and sausage)	0.018
			08.03.05	Sausage	0.35
			08.03.07. 03	Dried meat crisps	0.26
6	Polyoxyethylene (20) sorbitan monooleat	Emulsifier	16.03	Collagen casing	0.5	-	1) Accepted on August 11, 2023. Acceptance code: 衛食添新申字(2023)第0049號; 2) Issued for public comments on October 26, 2023; 3) It has not been officially approved yet.
7	Rosemary extract	Antioxidant	04.05.02	Processed nuts and seeds	0.3	-	1) Accepted on September 7, 2023. Acceptance code: 衛食添新申字(2023)第0053號; 2) Issued for public comments on October 26, 2023; 3) It has not been officially approved yet.
8	Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate)	Antioxidant	16.07	Others (Lutein Esters only)	50	-	1) Accepted on June 2, 2023. Acceptance code: 衛食添新申字(2023)第0038號; 2) Issued for public comments on October 26, 2023; 3) It has not been officially approved yet.
9	Ascorbyl palmitate (enzymatic)	Antioxidant	01.03	Milk powder (including sweetened milk powder) , cream powder and its formulated products	0.2	Count as ascorbic acid in fat	1) Accepted on November 8, 2023. Acceptance code: 衛食添新申字(2023)第0069號; 2) Issued for public comments on December 29, 2023; 3) It has not been officially approved yet.
			07.01	Bread	0.2
			14.05.01	Tea drinks	0.2	Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.
10	Sucralose	Sweetener	04.05.02.01.01	Shelled and cooked processed nuts and seeds	4.0	-	1) Accepted on January 10, 2023. Acceptance code: 衛食添新申字(2023)第0013號; 2) Issued for public comments on December 29, 2023; 3) It has not been officially approved yet.
10	Sucralose	Sweetener	04.05.02.01.02	Unshelled and cooked processed nuts and seeds	2.0	-

(5) Food processing aids with expanded scope issued for public comments (3 types)

S.N.	Name	Function	Applicable scope	Approval status (By the end of December 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)第0095號; 2) Issued for public comments on February 10, 2023; 3) Officially approved on August 1, 2023 according to Notice No. 5 of 2023.
2	Edible tannin	clarifying agent	Sugar technology	1) Accepted on March 6, 2023. Acceptance code: 衛食添新申字(2023)第0029號; 2) Issued for public comments on June 26, 2023; 3) Officially approved on December 1, 2023 according to Notice No. 10 of 2023.
3	Ethyl acetate	Extracting solvent	Processing technology of tea extracts	1) Accepted on November 11, 2022. Acceptance code: 衛食添新申字(2022)第0083號; 2) Issued for public comments on June 26, 2023; 3) Officially approved on December 1, 2023 according to Notice No. 10 of 2023.

S.N.

Name

Function

Applicable scope

Approval status (By the end of December 2023)

Sulfuric acid

Neutralizing and removing soap

Processing technology of oil

1) Accepted on December 19, 2022. Acceptance code: 食添新申字(2022)第0095號;

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

3) Officially approved on August 1, 2023 according to Notice No. 5 of 2023.

Edible tannin

clarifying agent

Sugar technology

1) Accepted on March 6, 2023. Acceptance code: 衛食添新申字(2023)第0029號;

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

3) Officially approved on December 1, 2023 according to Notice No. 10 of 2023.

Ethyl acetate

Extracting solvent

Processing technology of tea extracts

1) Accepted on November 11, 2022. Acceptance code: 衛食添新申字(2022)第0083號;

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

3) Officially approved on December 1, 2023 according to Notice No. 10 of 2023.

Approved new food additives in 2023 (33 types)

In 2023, 33 new food additives were approved by NHC, including 18 new food additives, and 15 food additives with expanded use and scope. Notably, ascorbyl palmitate (enzymatic) was approved as both a food additive and a nutrition enhancer with expanded use. Detailed information is as follows:

(1) Approved new food enzymes (12 types)

S.N.	Name	Source	Donor	Approval status (As of the end of December 2023)
1	Aminopeptidase	Aspergillus oryzae	Aspergillus oryzae	1) Accepted on March 7, 2022. Acceptance code: 衛食添新申字(2022)第0010號; 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: 衛食添新申字(2022)第0017號; 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:衛食添新申字(2021)第0014號; 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: 衛食添新申字(2022)第0009號; 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-galactosidase)	Papiliotrema terrestris	-	1) Accepted on April 26, 2022. Acceptance code: 衛食添新申字(2022)第0016號; 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: 衛食添新申字(2022)第0001號; 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: 衛食添新申字(2020)第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: 衛食添新申字(2022)第0033號; 2) Issued for public comments on December 8, 2022; 3) Officially approved on May 6, 2023 according to No. 3 of 2023.
10	Beta-amylase	Bacillus flexus	—	1) Accepted on July 7, 2021. Acceptance code: 衛食添新申字(2021)第0029號; 2) Issued for public comments on February 10, 2023; 3) Officially approved on August 1, 2023 according to No. 5 of 2023.
11	Lysophospholipase (lecithinase B)	Trichoderma reesei	Aspergillus nishimura	1) Accepted on July 15, 2022. Acceptance code: 衛食添新申字(2022)第0063號; 2) Issued for public comments on February 10, 2023. 3) Officially approved on August 1, 2023 according to No. 5 of 2023.
12	Serine proteas	Bacillus licheniformis	Nocardiopsis prasina	1) Accepted on May 10, 2022. Acceptance code: 衛食添新申字(2022)第0018號; 2) Issued for public comments on April 24, 2023; 3) Officially approved on October 7, 2023 according to No. 8 of 2023.

Note: The quality specifications of food enzymes shall meet the requirements specified in the National Food Safety Standard - Food Additives and Enzymes (GB 1886.174).

(2) Approved new food additives (1 type)

S.N.

Name

Function

Category number

Food name/

category

Maximum levels (g/L)

Acceptance information, issuance for public comments and approval

(As of the end of December 2023)

Potassium Polyaspartate

Stabilizer and coagulant

15.03.01

Grape wine

0.3

1) Accepted on May 9, 2020. Acceptance code: 衛食添新申字(2020)第0024號;

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

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

(3) New spice for food (1 type)

S.N.

Name

Function

Category number

Food name/

category

Maximum level (g/L)

Acceptance information, issuance for public comments and approval

(As of the end of December 2023)

2-Hexylpyridine

Spice for food

Prepared as spices food for use in various types of food (excluding food categories listed in Table B.1 of GB 2760-2014)

Appropriate level

1) Accepted on May 23, 2022. Acceptance code: 衛食添新申字(2022)第0021號;

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

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

(4) New food nutrition enhancers (4 types)

S.N.	Name	Applicable scope	Use levels	Information on producing bacteria	Acceptance information, issuance for public comments and approval (As of the end of December 2023)
1	L-Se-methylselenocysteine	The scope of use and dosage of L-Se-methylselenocysteine shall comply with the requirements for selenium as specified in the National Food Safety Standard for the Use of Food Nutrition Enhancer (GB14880)			1) Accepted on June 13, 2022. Acceptance code: 衛食添新申字(2022)第0035號; 2) Issued for public comments on August 19, 2022; 3) Officially approved on May 6, 2023 according to No. 3 of 2023.
2	Magnesium lactate	The scope of use and dosage of magnesium lactate shall comply with the requirements for magnesium as specified in the National Food Safety Standard for the Use of Food Nutrition Enhancer (GB14880)			1) Accepted on June 20, 2022. Acceptance code: 衛食添新申字(2022)第0038號; 2) Issued for public comments on December 8, 2022; 3) Officially approved on October 7, 2023 according to No. 8 of 2023.
3	2’-fucosyllactose, 2’-FL	01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose	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), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).	Source: E. coli K-12 DH1 MDO Donor: Helicobacter spp.	1) Accepted on October 18, 2021, and November 3, 2021, respectively. Acceptance code: 衛食添新申字(2021)第0048號 and 衛食添新申字(2021)第0050號; 2) Issued for public comments, on April 15, 2022 and October 28, 2022, respectively; 3) Officially approved on October 7, 2023 according to No. 8 of 2023.
				Source: E. coli K-12 MG1655 Donor: Helicobacter spp.
				Source: E. coli BL21(DE3) Donor: Neisseria spp.	1) Accepted on January 5, 2023. Acceptance code: 衛食添新申字(2023)第0003號; 2) Issued for public comments on February 10, 2023. 3) Officially approved on October 7, 2023 according to No. 8 of 2023.
4	Lacto-N-neotetraose, LNnT	01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose	0.2-0.6 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 2’-fucosyllactose, galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount shall not exceed 64.5 (g/kg).	Source: E. coli K-12 DH1 MDO Donor: Neisseria spp. and Helicobacter spp.	1) Accepted on October 18, 2021. Acceptance code: 衛食添新申字(2021)第0049號; 2) Issued for public comments on October 28, 2022; 3) Officially approved on October 7, 2023 according to No. 8 of 2023.

(5) Approved new food additives with expanded scope and use (7 types)

S.N.	Name	Function	Category number	Food name/category	Maximum levels (g/kg)			Acceptance information, issuance for public comments and approval (As of the end of December 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: 衛食添新申字(2022)第0040號; 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, barbecued, and roasted meats
			08.03.03	Fried meats
			08.03.05	Sausages
			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: 衛食添新申字(2022)第0039號; 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, barbecued, and roasted meats
			08.03.03	Fried meats
			08.03.05	Sausages
			09.02.02	Frozen coating products
			09.04.02	Cooked or fired aquatic products
			09.04.03	Smoked, baked aquatic products
3	Sodium cyclamate, calcium cyclamate	Sweetener	07.04	Fillings and surface spreading starch for bakery food (for bakery food fillings only)	2.0		Count as cyclamic acid	1) Accepted on July 12, 2022. Acceptance code: 衛食添新申字(2022)第0060號; 2) Issued for public comments on October 28, 2022; 3) Officially approved on March 2, 2023 according to No. 1 of 2023.
3	Sodium cyclamate, calcium cyclamate	Sweetener	16.06	Puffed foods	0.2		Count as cyclamic 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	Calcium lactate	Stabilizer coagulant, and acidity regulator	04.02.02.03	Pickled vegetables	10.0			1) Accepted on January 5, 2023. Acceptance code: 衛食添新申字(2023)第0002號; 2) Issued for public comments on April 24, 2023. 3) Officially approved on October 7, 2023 according to No. 8 of 2023.
6	Calcium lactate	Stabilizer coagulant, and acidity regulator	04.02.02.04	Canned vegetables	3.0
7	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) Officially approved on October 7, 2023 according to No. 8 of 2023.
			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

(6) Approved processing aids with expanded scope and use (5 types)

S.N.	Name	Function	Applicable scope	Approval status (By the end of December 2023)
1	Polydimethylsiloxane and emulsion	Defoamer	Processing technology of collagen casing	1) Acceptance code: 衛食添新申字(2018)第0018號; 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: 衛食添新申字(2022)第0007號; 2) Issued for public comments on July 1, 2022; 3) Officially approved on March 2, 2023 according to No. 1 of 2023.
3	Sulfuric acid	Neutralizing and removing soap	Processing technology of oil	1) Accepted on December 19, 2022. Acceptance code: 食添新申字(2022)第0095號; 2) Issued for public comments on February 10, 2023; 3) Officially approved on August 1, 2023 according to No. 5 of 2023.
4	Edible tannin	Clarifying agent	Processing technology of sugar	1) Accepted on March 6, 2023. Acceptance code: 衛食添新申字(2023)第0029號; 2) Issued for public comments on June 26, 2023; 3) Officially approved on December 1, 2023 according to No. 10 of 2023.
5	Ethyl acetate	Extraction solvent	Processing technology of tea extracts	1) Accepted on November 11, 2022. Acceptance code: 衛食添新申字(2022)第0083號; 2) Issued for public comments on June 26, 2023; 3) Officially approved on December 1, 2023 according to No. 10 of 2023.

(7) Approved food nutrition enhancers with expanded scope and use (4 types)

S.N.	Name	Category number	Food name/category	Maximum levels	Approval status (By the end of December 2023)
1	Vitamin B1	14.04.2.01	Drinks for special uses (including sports drinks and nutritional beverages)	2 mg/kg-5 mg/kg	1) Accepted on October 31, 2022. Acceptance code: 衛食添新申字(2022)第0076號; 2) Issued for public comments on December 8, 2022; 3) Officially approved on May 6, 2023 according to No. 3 of 2023.
2	Vitamin B2	14.04.02.01	Drinks for special uses (including sports drinks and nutritional beverages)	2 mg/kg-5 mg/kg	1) Accepted on October 31. 2022. Acceptance code: 衛食添新申字(2022)第0077號; 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 nutritional beverages)	0.1 g/kg-0.6 g/kg	1) Accepted on October 31. 2022. Acceptance code: 衛食添新申字(2022)第0075號; 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 of Vitamin C, its scope of use and maximum levels shall comply with the provisions of GB 14880.			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.

CIRS opinion

It can be observed from the analysis above that new food enzymes still dominate, comprising the largest share at 35.29%, the majority of which are derived from genetically modified sources. However, the percentage of newly approved food additives (52.94%) this year is higher than that of food additives with expanded use (47.05%). Notably, according to Notice No. 8 of 2023, one Lacto-N-neotetraose of microbial source and three 2’-fucosyllactose of microbial sources, two types of highly anticipated HMOs, were successfully approved this year, which is expected to further enrich the infant formula market.

Compared to the first quarter of 2022, the number of substances accepted in the first quarter of this year has significantly increased, more than doubling from the same period last year, yet most of the review outcomes were unsatisfactory. This indicates that the official standards for the review of food additives have become more stringent. In the future, applicants should be well-prepared in terms of product safety and technical necessity in response to the review process. In the case of products that are not approved, companies can better organize and prepare the necessary files, and resubmit the application based on the review results.

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Analysis on the Application and Approval of New Food Additives in 2023

Overview of new food additives accepted, issued for public comments and approved in 2023

New food additives accepted by NHC in 2023 (82 types)

New food additives that have passed the technical review and were issued for public comments in 2023 (22 types)

(1) New food enzymes issued for public comments (6 types)

(2) New food additives issued for public comments (2 types)

(3) New nutrition enhancers issued for public comments (1 type)

(4) Food additives with expanded scope issued for public comments (10 types)

(5) Food processing aids with expanded scope issued for public comments (3 types)

Approved new food additives in 2023 (33 types)

(1) Approved new food enzymes (12 types)

(2) Approved new food additives (1 type)

(3) New spice for food (1 type)

(4) New food nutrition enhancers (4 types)

(5) Approved new food additives with expanded scope and use (7 types)

(6) Approved processing aids with expanded scope and use (5 types)

(7) Approved food nutrition enhancers with expanded scope and use (4 types)

CIRS opinion