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.
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.
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 “卫食添新申字”. Detailed information is shown in the Table below:
No. |
Acceptance date |
Acceptance code |
Name of new food additives |
---|---|---|---|
1 |
2023.01.03 |
卫食添新申字(2023)第0001号 |
Phosphoric acid (Wet process) |
2 |
2023.01.05 |
卫食添新申字(2023)第0002号 |
Calcium lactate |
3 |
2023.01.05 |
卫食添新申字(2023)第0003号 |
2’-fucosyllactose, 2’-FL |
4 |
2023.01.10 |
卫食添新申字(2023)第0004号 |
Calcium chloride |
5 |
2023.01.10 |
卫食添新申字(2023)第0005号 |
Sodium metabisulphite |
6 |
2023.01.10 |
卫食添新申字(2023)第0006号 |
Benzoic acid, sodium benzoate |
7 |
2023.01.10 |
卫食添新申字(2023)第0007号 |
Sorbic acid, potassium sorbate |
8 |
2023.01.10 |
卫食添新申字(2023)第0008号 |
Ascorbic acid |
9 |
2023.01.10 |
卫食添新申字(2023)第0009号 |
Paprika red |
10 |
2023.01.10 |
卫食添新申字(2023)第0010号 |
Lactic acid |
11 |
2023.01.10 |
卫食添新申字(2023)第0011号 |
Acesulfame potassium |
12 |
2023.01.10 |
卫食添新申字(2023)第0012号 |
Paprika oleoresin |
13 |
2023.01.10 |
卫食添新申字(2023)第0013号 |
Sucralose |
14 |
2023.01.10 |
卫食添新申字(2023)第0014号 |
Tartrazine |
15 |
2023.01.10 |
卫食添新申字(2023)第0015号 |
D-isoascorbic acid (erythorbic acid) , sodium D-isoascorbate |
16 |
2023.01.10 |
卫食添新申字(2023)第0016号 |
Disodium 5'-ribonucleotide |
17 |
2023.01.10 |
卫食添新申字(2023)第0017号 |
Citric acid |
18 |
2023.01.10 |
卫食添新申字(2023)第0018号 |
Dehydroacetic acid, sodium dehydroacetate |
19 |
2023.01.10 |
卫食添新申字(2023)第0019号 |
Disodium ethylene-diamine-tetra-acetate |
20 |
2023.01.10 |
卫食添新申字(2023)第0020号 |
Hydroxytyrosol |
21 |
2023.01.12 |
卫食添新申字(2023)第0021号 |
Nitrous oxide |
22 |
2023.01.28 |
卫食添新申字(2023)第0022号 |
NMN (β-Nicotinamide mononucleotide) |
23 |
2023.01.29 |
卫食添新申字(2023)第0023号 |
Propylene glycol alginate |
24 |
2023.02.02 |
卫食添新申字(2023)第0024号 |
D-3-hydroxybutyric acid |
25 |
2023.02.17 |
卫食添新申字(2023)第0025号 |
Runmai improver |
26 |
2023.02.27 |
卫食添新申字(2023)第0026号 |
Carmine cochineal |
27 |
2023.03.03 |
卫食添新申字(2023)第0027号 |
Vitamin K2 (synthesis method) |
28 |
2023.03.03 |
卫食添新申字(2023)第0028号 |
Cyclomaltodextin glucanotransferase |
29 |
2023.03.06 |
卫食添新申字(2023)第0029号 |
Edible tannin |
30 |
2023.03.06 |
卫食添新申字(2023)第0030号 |
Rebaudioside M |
31 |
2023.03.30 |
卫食添新申字(2023)第0031号 |
Corderan gum |
32 |
2023.04.23 |
卫食添新申字(2023)第0032号 |
D-psicose 3-epimerase |
33 |
2023.05.04 |
卫食添新申字(2023)第0033号 |
6’-sialyllactose sodium salt, 6’-SL |
34 |
2023.05.10 |
卫食添新申字(2023)第0034号 |
Rebaudioside M |
35 |
2023.05.22 |
卫食添新申字(2023)第0035号 |
Xylanase |
36 |
2023.05.25 |
卫食添新申字(2023)第0036号 |
Sodium sulfide pentahydrate |
37 |
2023.05.31 |
卫食添新申字(2023)第0037号 |
Propylene glycol alginate |
38 |
2023.06.02 |
卫食添新申字(2023)第0038号 |
Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate) |
39 |
2023.07.03 |
卫食添新申字(2023)第0039号 |
L-alanine |
40 |
2023.07.04 |
卫食添新申字(2023)第0040号 |
Ramie Leaf Extract |
41 |
2023.07.04 |
卫食添新申字(2023)第0041号 |
Stevia glycoside |
42 |
2023.07.05 |
卫食添新申字(2023)第0042号 |
Tetrapotassium pyrophosphate |
43 |
2023.07.06 |
卫食添新申字(2023)第0043号 |
Sucralose |
44 |
2023.07.13 |
卫食添新申字(2023)第0044号 |
Nitric acid |
45 |
2023.07.14 |
卫食添新申字(2023)第0045号 |
2’-fucosyllactose, 2’-FL |
46 |
2023.07.17 |
卫食添新申字(2023)第0046号 |
6’-Sialyllactose sodium salt, 6’-SL |
47 |
2023.07.17 |
卫食添新申字(2023)第0047号 |
3’-Sialyllactose sodium salt, 3’-SL |
48 |
2023.08.01 |
卫食添新申字(2023)第0048号 |
Potassium sorbate |
49 |
2023.08.11 |
卫食添新申字(2023)第0049号 |
Polyoxyethylene (20) sorbitan monooleat |
50 |
2023.09.04 |
卫食添新申字(2023)第0050号 |
Lycopene |
51 |
2023.09.06 |
卫食添新申字(2023)第0051号 |
(6S)-5-methyltetrahydrofolic acid, glucosamine salt |
52 |
2023.09.06 |
卫食添新申字(2023)第0052号 |
Butylated hydroxytoluene (BHT) |
53 |
2023.09.07 |
卫食添新申字(2023)第0053号 |
Rosemary extract |
54 |
2023.09.15 |
卫食添新申字(2023)第0054号 |
Hydroxytyrosol |
55 |
2023.09.18 |
卫食添新申字(2023)第0055号 |
Sanzan Gum |
56 |
2023.09.18 |
卫食添新申字(2023)第0056号 |
Sanzan Gum |
57 |
2023.09.18 |
卫食添新申字(2023)第0057号 |
Lactase (beta-galactosidase) |
58 |
2023.09.19 |
卫食添新申字(2023)第0058号 |
2’-fucosyllactose, 2’-FL |
59 |
2023.09.20 |
卫食添新申字(2023)第0059号 |
2’-fucosyllactose, 2’-FL |
60 |
2023.09.20 |
卫食添新申字(2023)第0060号 |
Nitrous oxide |
61 |
2023.09.20 |
卫食添新申字(2023)第0061号 |
2’-fucosyllactose, 2’-FL |
62 |
2023.09.21 |
卫食添新申字(2023)第0062号 |
3’-Sialyllactose sodium salt, 3’-SL |
63 |
2023.09.22 |
卫食添新申字(2023)第0063号 |
Phosphodiesterase I |
64 |
2023.11.01 |
卫食添新申字(2023)第0064号 |
2’-fucosyllactose, 2’-FL |
65 |
2023.11.01 |
卫食添新申字(2023)第0065号 |
2’-fucosyllactose, 2’-FL |
66 |
2023.11.03 |
卫食添新申字(2023)第0066号 |
Glucoamylase |
67 |
2023.11.03 |
卫食添新申字(2023)第0067号 |
Serine protease |
68 |
2023.11.06 |
卫食添新申字(2023)第0068号 |
Tripotassium citrate |
69 |
2023.11.08 |
卫食添新申字(2023)第0069号 |
Ascorbyl palmitate (enzymatic) |
70 |
2023.11.13 |
卫食添新申字(2023)第0070号 |
Zinc sulfate |
71 |
2023.11.20 |
卫食添新申字(2023)第0071号 |
Lactase (beta-galactosidase) |
72 |
2023.11.20 |
卫食添新申字(2023)第0072号 |
Lipase |
73 |
2023.11.20 |
卫食添新申字(2023)第0073号 |
Calcium carbonate (seaweed source) |
74 |
2023.11.21 |
卫食添新申字(2023)第0074号 |
3-fucosyllactose, 3-FL |
75 |
2023.11.21 |
卫食添新申字(2023)第0075号 |
Sodium sulfide pentahydrate |
76 |
2023.11.30 |
卫食添新申字(2023)第0076号 |
2’-fucosyllactose, 2’-FL |
77 |
2023.11.30 |
卫食添新申字(2023)第0077号 |
Cellulose |
78 |
2023.12.08 |
卫食添新申字(2023)第0078号 |
Sanzan Gum |
79 |
2023.12.11 |
卫食添新申字(2023)第0079号 |
Selenium-enriched yeast |
80 |
2023.12.25 |
卫食添新申字(2023)第0080号 |
Pomelone [(8E) -undecan-6,8, 10-triene-3-ketone] |
81 |
2023.12.25 |
卫食添新申字(2023)第0081号 |
(E)-6-Octenal |
82 |
2023.12.29 |
卫食添新申字(2023)第0082号 |
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 |
— |
|
2 |
Lysophospholipase (lecithinase B) |
Trichoderma reesei |
Aspergillus nishimurae |
|
3 |
Serine protease |
Bacillus licheniformis |
Nocardiopsis prasina |
|
4 |
Cyclomaltodextin glucanotransferase |
Anoxybacillus caldiproteolyticus |
— |
|
5 |
Cellulase |
Penicillium oxalicum |
— |
|
6 |
D-psicose 3-epimerase |
Bacillus subtilis |
Clostridium scindens ATCC35704 |
|
(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) |
|
2 |
Rebaudioside M |
Sweetener |
01.01.03 |
Modified milk |
0.18 (count as steviols) |
|
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. |
|
Source: Corynebacterium glutamate ATCC 13032; Donor: Pseudopedobacter saltans |
|
||||
Source: Escherichia coli BL21(DE3); Donor: Helicobacter pylori |
|
(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 |
- |
|
04.02.02.04 |
Canned vegetables |
3.0 |
- |
||||
2 |
Sanzan Gum |
Thickener, stabilizer and coagulant |
01.01.03 |
Modified milk |
0.5 |
- |
|
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 |
- |
|
|||
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. |
|
4 |
Propylene glycol alginate |
Thickener |
06.05.02.01 |
Bean vermicelli, bean noodles |
1.5 |
- |
|
06.05.02.04 |
Round rice ball |
||||||
5 |
Lycopene |
Colorant |
08.02.01 |
Seasoned meat products (adding seasonings to fresh meats) |
0.12 |
Count as lycopene |
|
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 |
- |
|
7 |
Rosemary extract |
Antioxidant |
04.05.02 |
Processed nuts and seeds |
0.3 |
- |
|
8 |
Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate) |
Antioxidant |
16.07 |
Others (Lutein Esters only) |
50 |
- |
|
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 |
|
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 |
- |
|
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 |
|
2 |
Edible tannin |
clarifying agent |
Sugar technology |
|
3 |
Ethyl acetate |
Extracting solvent |
Processing technology of tea extracts |
|
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: 卫食添新申字(2022)第0010号; 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: 卫食添新申字(2022)第0017号; 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:卫食添新申字(2021)第0014号; 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: 卫食添新申字(2022)第0009号; 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: 卫食添新申字(2022)第0016号; 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: 卫食添新申字(2022)第0001号; 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: 卫食添新申字(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: 卫食添新申字(2022)第0033号; 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: 卫食添新申字(2021)第0029号; 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: 卫食添新申字(2022)第0063号; 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: 卫食添新申字(2022)第0018号; 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) |
1 |
Potassium Polyaspartate |
Stabilizer and coagulant |
15.03.01 |
Grape wine |
0.3 |
1) Accepted on May 9, 2020. Acceptance code: 卫食添新申字(2020)第0024号; 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) |
1 |
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: 卫食添新申字(2022)第0021号; 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: 卫食添新申字(2022)第0035号; 2) Issued for public comments on August 19, 2022; 3) Officially approved on May 6, 2023 according to No. 3 of 2023. |
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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: 卫食添新申字(2022)第0038号; 2) Issued for public comments on December 8, 2022; 3) Officially approved on October 7, 2023 according to No. 8 of 2023. |
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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: 卫食添新申字(2021)第0048号 and 卫食添新申字(2021)第0050号; 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. |
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Source: E. coli BL21(DE3) Donor: Neisseria spp. |
1) Accepted on January 5, 2023. Acceptance code: 卫食添新申字(2023)第0003号; 2) Issued for public comments on February 10, 2023. 3) Officially approved on October 7, 2023 according to No. 8 of 2023. |
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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: 卫食添新申字(2021)第0049号; 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) |
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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: 卫食添新申字(2022)第0040号; 2) Issued for public comments on August 19, 2022; 3) Officially approved on March 2, 2023 according to No. 1 of 2023. |
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08.03.02 |
Smoked, barbecued, and roasted meats |
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08.03.03 |
Fried meats |
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08.03.05 |
Sausages |
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09.02.02 |
Frozen coating products |
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09.04.02 |
Cooked or fired aquatic products |
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09.04.03 |
Smoked, baked aquatic products |
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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: 卫食添新申字(2022)第0039号; 2) Issued for public comments on August 19, 2022; 3) Officially approved on March 2, 2023 according to No. 1 of 2023. |
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08.03.02 |
Smoked, barbecued, and roasted meats |
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08.03.03 |
Fried meats |
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08.03.05 |
Sausages |
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09.02.02 |
Frozen coating products |
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09.04.02 |
Cooked or fired aquatic products |
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09.04.03 |
Smoked, baked aquatic products |
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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: 卫食添新申字(2022)第0060号; 2) Issued for public comments on October 28, 2022; 3) Officially approved on March 2, 2023 according to No. 1 of 2023. |
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16.06 |
Puffed foods |
0.2 |
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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. |
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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. |
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6 |
Calcium lactate |
Stabilizer coagulant, and acidity regulator |
04.02.02.03 |
Pickled vegetables |
10.0 |
1) Accepted on January 5, 2023. Acceptance code: 卫食添新申字(2023)第0002号; 2) Issued for public comments on April 24, 2023. 3) Officially approved on October 7, 2023 according to No. 8 of 2023. |
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04.02.02.04 |
Canned vegetables |
3.0 |
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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. |
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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. |
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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: 卫食添新申字(2018)第0018号; 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: 卫食添新申字(2022)第0007号; 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号; 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: 卫食添新申字(2023)第0029号; 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: 卫食添新申字(2022)第0083号; 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: 卫食添新申字(2022)第0076号; 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: 卫食添新申字(2022)第0077号; 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: 卫食添新申字(2022)第0075号; 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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