Analysis on the Approval Status of New Food Additives in the First Half of 2023 - Regulatory News - Food & Food Contact Materials

As of the end of June 2023, the National Health Commission of the People’s Republic of China (NHC) issued two announcements (No. 1 of 2023, No. 3 of 2023) in which a total of 42 products were approved. 22 of them were new food additives (including those for expanded use).

CIRS Group will introduce more detailed information about the acceptance and approval of new food additives in China in the first half of 2023 as following:

Overview of the approval status of new food additives in the first half of 2023

Figure 1. Overview of new food additives approval status in the first half of 2023

List of new food additives accepted in the first half of 2023 (38 types)

In the first half of 2023, NHC had accepted 38 new food additives applications (including those for expanded use). Detailed information is shown in the table:

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	3,4-Dihydroxypheny lethanol
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-hydroxybutyrate
25	2023-02-17	衛食添新申字(2023)第0025號	Moistening wheat 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	Curdlan
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)

Note: Substances in blue were rejected.

List of new food additives issued for public comments in the first half of 2023 (11 types)

In the first half of 2023, 11 new food additives have passed the technical review of CFSA and were issued for public comments. Detailed information is as follows.

1) List of new food enzymes (3 types)

No.	Name	Source	Donor	Approval status (By the end of June 2023)
1	beta-amylase	Bacillus flexus	—	1) Issued for public comments on February 10, 2023; 2) It has not been officially approved.
2	Lysophospholipase （lecithinase B）	Trichoderma reesei	Aspergillus nishimurae	1) Accepted on July 15, 2023. Acceptance code: 衛食添新申字(2022) No. 0063; 2) Issued for public comments on February 10, 2023; 3) It has not been officially approved.
3	Serine protease	Bacillus licheniformis	Nocardiopsis prasina	1) Accepted on May 10, 2022. Acceptance code: Acceptance code: 衛食添新申字(2022) No.0018; 2) Issued for public comments on April 24, 2023; 3) It has not been officially approved.

No.

Name

Source

Donor

Approval status

(By the end of June 2023)

beta-amylase

Bacillus flexus

—

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

2) It has not been officially approved.

Lysophospholipase （lecithinase B）

Trichoderma reesei

Aspergillus nishimurae

1) Accepted on July 15, 2023. Acceptance code: 衛食添新申字(2022) No. 0063;

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

3) It has not been officially approved.

Serine protease

Bacillus licheniformis

Nocardiopsis prasina

1) Accepted on May 10, 2022. Acceptance code: Acceptance code: 衛食添新申字(2022) No.0018;

2) Issued for public comments on April 24, 2023;

3) It has not been officially approved.

2) List of new food additives (1 type)

No.

Name

Function

Category number

Food name/

category

Maximum level (g/kg)

Approval status

(By the end of June 2023)

Mixed tocotrienol concentrate

Antioxidant

02.01.01

Vegetables 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) No. 0037;

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

3) It has not been officially approved.

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 2023）
1	2'-fucosyllactose	01.03.02	Modified milk powder (limited to milk powder for children)	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), oligo-galactose, oligofructose, polyfructose and raffinose, the total amount of 2'-fucosyllactose shall must not exceed 64.5 (g/kg).	1) Accepted on January 5, 2023. Acceptance code: 衛食添新申字(2023) No. 003; 2) Issued for public comments on February 10, 2023; 3) It has not been officially approved.
		13.01.01	Infant formula foods
		13.01.02	Formula for older infants and young children
		13.01.03	Infant formula food for special medical purpose
	Source: E. coli BL21(DE3); Donor: Neisseria spp.

4) List of food additives for expanded scope (3 types)

No.	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Note	Approval status (By the end of June 2023)
1	Sanzan Gum	Thickener, stabilizer and coagulant	01.01.03	Modified milk	0.5	-	1）No acceptance information found; 2）Issued for public comments on February 10, 2023; 3）It has not been officially approved.
			03.01	Ice cream and ice 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
2	Calcium lactate	Stabilizer and coagulant, 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) No. 0002; 2）Issued for public comments on April 24, 2023; 3）It has not been officially approved.
2	Calcium lactate	Stabilizer and coagulant, acidity regulator	04.02.02.04	Canned vegetable	3.0	-
3	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) It has not been officially approved.
			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

5) List of new food processing aid with expanded scope (3 types)

No.	Name	Function	Usage scope	Approval status (By the end of June 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) No.0095; 2) Issued for public comments on February 10, 2023; 3) It has not been officially approved.
2	Edible tannin	Clarifying agent	Processing technology of sugar	1) Accepted on March 6, 2023. Acceptance code: 衛食添新申字(2023) No.0029; 2) Issued for public comments on June 26, 2023; 3) It has not been officially approved.
3	Ethyl acetate	Extracting solvent	Processing technology of tea extract	1) Accepted on November 11, 2022. Acceptance code: 衛食添新申字(2022) No.0083; 2) Issued for public comments on June 26, 2023; 3) It has not been officially approved.

No.

Name

Function

Usage scope

Approval status

(By the end of June 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) No.0095;

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

3) It has not been officially approved.

Edible tannin

Clarifying agent

Processing technology of sugar

1) Accepted on March 6, 2023. Acceptance code: 衛食添新申字(2023) No.0029;

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

3) It has not been officially approved.

Ethyl acetate

Extracting solvent

Processing technology of tea extract

1) Accepted on November 11, 2022. Acceptance code: 衛食添新申字(2022) No.0083;

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

3) It has not been officially approved.

List of new food additives approved in the first half of 2023 (22 types)

In the first half of 2023, a total of 22 new food additives were approved by NHC, including 12 new food additives and 10 food additives for expanded scope and use. Detailed information is as follows:

1) List of approved new food enzymes (9 types)

No.	Name	Source	Donor	Approval status (By the end of June 2023)
1	Aminopeptidase	Aspergillus oryzae	Aspergillus oryzae	1) Accepted on March 7, 2022. Acceptance code: 衛食添新申字(2022) No. 0010; 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) No. 0017; 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) No. 0014 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) No. 0009; 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-alactosidase）	Papiliotrema terrestris	-	1) Accepted on April 26, 2022. Acceptance code: 衛食添新申字(2022) No. 0016; 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) No. 0001; 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) No. 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) No. 0033; 2) Issued for public comments on December 8, 2022; 3) Officially approved on May 6, 2023 according to No. 3 of 2023.

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

2) List of approved new food additives (1 type)

No.

Name

Function

Category number

Food name/category

Maximum level（g/L）

Approval Status

(By the end of June 2023)

Potassium Polyaspartate

Stabilizer and coagulator

15.03.01

Grape wine

0.3

1) Accepted on May 9, 2020. Acceptance code: 衛食添新申字(2020) No. 0024;

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

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

3) List of new food flavor substance (1 type)

No.

Name

Function

Category number

Food name/category

Maximum level

Approval Status

(By the end of June 2023)

2-Hexylpyridine

Food flavor substance

Formulated into food flavors for all types of food (except food category 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) No. 0021;

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

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

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

No.

Name

Dosage and scope of use

Approval Status

(By the end of June 2023)

L-Se-methylselenocysteine

The scope of use and dosage of L-Se-methylselenocysteine shall compy with the provisions of selenium approved in GB14880 "National Food Safety Standard for the Use of Food Nutrition Enhancer".

1) Accepted on June 13, 2022.Acceptance code: 衛食添新申字(2022) No. 0035;

2) Issued for public comments on August 19, 2022;

3) Officially approved on May 6, 2023 according to No. 3 of 2023.

5) List of approved new food additives with expanded scope and use (5 types)

No.	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Approval Status (By the end of June 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) No. 0040; 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, baked, or grilled meat
			08.03.03	Fried meats
			08.03.05	Sausage
			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) No. 0039; 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, baked, or grilled meat
			08.03.03	Fried meats
			08.03.05	Sausage
			09.02.02	Frozen coating products
			09.04.02	Cooked or fired aquatic products
			09.04.03	Smoked, baked aquatic products
3	Sodium cyclamate	Sweetener	07.04	Fillings and topping syrups for bakeries (fillings of crackers only)	2.0 (count as cyclohexyl sulfamic acid	1）Accepted on July 12, 2022. Acceptance code: 衛食添新申字(2022) No. 0060; 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	Sweetener	16.06	Puffed food	0.2 (count as cyclohexyl sulfamic 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) List of approved processing aids with expanded scope and use (2 types)

No.	Name	Function	Usage scope	Approval Status (By the end of June 2023)
1	polydimethylsiloxane and emulsion	Defoamer	Production and processing technology of collagen casings	1) Acceptance code: 衛食添新申字(2018) No. 0018; 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) No. 0007; 2) Issued for public comments on July 1, 2022; 3) Officially approved on March 2, 2023 according to No. 1 of 2023.

No.

Name

Function

Usage scope

Approval Status

(By the end of June 2023)

polydimethylsiloxane and emulsion

Defoamer

Production and processing technology of collagen casings

1) Acceptance code: 衛食添新申字(2018) No. 0018;

2) Issued for public comments on July 1, 2022;

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

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) No. 0007;

2) Issued for public comments on July 1, 2022;

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

7) List of approved food nutrition enhancer with expanded scope and use (4 types)

No.	Name	Category number	Food name/category	Maximum level	Approval Status (By the end of June 2023)
1	Vitamin B1	14.04.2.01	Drinks for special uses (including sports drinks and nutrient drinks)	2 mg/kg~5 mg/kg	1) Accepted on October 31, 2022. Acceptance code: 衛食添新申字(2022) No. 0076; 2) Issued for public comments on December 8, 2022； 3) Officially approved on March 2, 2023 according to No. 1 of 2023.
2	Vitamin B2	14.04.02.01	Drinks for special uses (including sports drinks and nutrient drinks)	2 mg/kg~5 mg/kg	1) Accepted on October 31. 2022. Acceptance code: 衛食添新申字(2022) No. 0077; 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 nutrient drinks)	0.1 g/kg~0.6 g/kg	1) Accepted on October 31. 2022. Acceptance number: 衛食添新申字(2022) No. 0075; 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 source of Vitamin C, its scope of use and dosage is consistent with the provisions in GB14880.			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.

Conclusion

Based on the statistics above, in the first half of 2023, new food enzymes, most which are from genetically modified sources, accounted for the largest proportion, with 39.1% approved and 27.2% issued for public comments. On May 6, NHC issued Announcement No.3 of 2023, clearly stipulating the strain number of D-psicose 3-epimerase donor strain for the first time. It shows that the official requirements for food enzymes have become more rigorous, and that enterprises’ R&D results are better protected.

In the first quarter of 2023, a large number of products were accepted by the NHC, twice as many as those accepted in the same period last year. However, most of the review results were unsatisfactory, this is because the requirements for food additives review became more stringent. In the future, food enterprises should make adequate preparations in the product safety and the necessity of technologies applied in products, to better cope with the review. Even if the products were rejected by the NHC, related enterprises may still rearrange their application materials by reference to the technical review results provided by the expert committee and submit their application for a second time.

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