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    Analysis on Application Approval of New Food Additives in China in 2022

    from CIRS by

    China,Food,Analysis,New,Additive,Application,Approval

    By the end of December 2022, the National Health Commission of the People's Republic of China (NHC) issued three announcements (No. 1 of 2022, No. 2 of 2022, No. 5 of 2022) in the form of "Three New Foods" with 75 products approved, including new food raw materials (novel food), new food additives and food-related products (new food contact substances). Among them, 32 kinds of new food additives (including expanded use) were approved.

    According to the NHC and the China National Center for Food Safety Risk Assessment (CFSA) websites, in 2022, a total of 97 new food additives applications were accepted, and 45 new food additives (including expanded use) passed the technical evaluation and were issued for public comments.

    This article provides you with detailed information about the acceptance and approval of new food additives in China in 2022.

    1. List of new food additives applications in 2022 (97 types)

    In 2022, a total of 97 new food additives (including expanded use) applications were accepted by the NHC. Since the acceptance code all begin with "衛食添新申字", there is no distinction between domestic and imported products.

    Several applications among them were issued rejection decisions: yellow pigment was rejected on March 8, 2022. Rebaudioside A, steviol glycosides, stevia extract, 6S-5-methyltetrahydrofolate calcium, serine protease and pyrrolidine -[1,2e] -4h-2, 4-dimethyl-1,3, 5-dithiazide were rejected on August 16, 2022. Nucleotide was rejected on September 14, 2022. Isomerized lactose (衛食添新申字(2022)0041 and 衛食添新申字(2022)0042), ammonium glycyrrhizinate were rejected on September 30, 2022. Xylanase was rejected on October 9, 2022. Sucralos, acesulfame potassium, mycelium extract of Cordyceps sinensis, curdlan, rock mineral selenium, gardenia yellow, riboflavin, monopotassium and tripotassium glycyrrhizinate, potassium bitartarate and vanillin (fermentation) were rejected on December 12, 2022. L-Alanine, nisin and tomato red were rejected on January 28, 2023.

     

    No.

    Acceptance date

    Acceptance Code

    Name of New Food Additives

    1

    2022.01.06

    衛食添新申字(2022)0001

    Carboxypeptidase

    2

    2022.01.10

    衛食添新申字(2022)0002

    Monascus yellow pigment

    3

    2022.01.30

    衛食添新申字(2022)0003

    Carmine cochineal

    4

    2022.02.11

    衛食添新申字(2022)0004

    Rebaudioside A

    5

    2022.02.11

    衛食添新申字(2022)0005

    Stevia glycosides

    6

    2022.02.11

    衛食添新申字(2022)0006

    Stevia extract

    7

    2022.02.16

    衛食添新申字(2022)0007

    Magnesium stearate

    8

    2022.03.03

    衛食添新申字(2022)0008

    L-alanine

    9

    2022.03.07

    衛食添新申字(2022)0009

    Xylanase

    10

    2022.03.07

    衛食添新申字(2022)0010

    Aminopeptidase

    11

    2022.03.08

    衛食添新申字(2022)0011

    L-leucine

    12

    2022.03.08

    衛食添新申字(2022)0012

    L-isoleucine

    13

    2022.03.08

    衛食添新申字(2022)0013

    L-valine

    14

    2022.03.21

    衛食添新申字(2022)0014

    6S-5-methyltetrahydrofolate calcium

    15

    2022.04.02

    衛食添新申字(2022)0015

    Maltose alpha-amylase

    16

    2022-04-26

    衛食添新申字(2022)0016

    Lactase (beta-galactosidase)

    17

    2022.04.28

    衛食添新申字(2022)0017

    Phospholipase A2

    18

    2022.05.10

    衛食添新申字(2022)0018

    Serine protease

    19

    2022.05.10

    衛食添新申字(2022)0019

    Serine protease

    20

    2022.05.10

    衛食添新申字(2022)0020

    Xylanase

    21

    2022.05.23

    衛食添新申字(2022)0021

    2-hexyl pyridine

    22

    2022.05.26

    衛食添新申字(2022)0022

    L-cystine

    23

    2022.05.26

    衛食添新申字(2022)0023

    L-cysteine hydrochloride monohydrate

    24

    2022.05.26

    衛食添新申字(2022)0024

    L-lysine acetate

    25

    2022.05.26

    衛食添新申字(2022)0025

    L-histidine

    26

    2022.05.26

    衛食添新申字(2022)0026

    L-threonine

    27

    2022.05.26

    衛食添新申字(2022)0027

    L-cysteine hydrochloride

    28

    2022.05.26

    衛食添新申字(2022)0028

    L-cysteine

    29

    2022.05.26

    衛食添新申字(2022)0029

    L-phenylalanine

    30

    2022.05.26

    衛食添新申字(2022)0030

    L-lysine hydrochloride

    31

    2022.05.26

    衛食添新申字(2022)0031

    L- histidine hydrochloride monohydrate

    32

    2022.05.27

    衛食添新申字(2022)0032

    Pyrrolidino -[1,2e] -4h-2,4-dimethyl-1,3,5-dithiazide

    33

    2022.06.02

    衛食添新申字(2022)0033

    D-psicose 3-epimerase

    34

    2022.06.09

    衛食添新申字(2022)0034

    Rock mineral selenium

    35

    2022.06.13

    衛食添新申字(2022)0035

    L-selenomethyl selenocysteine

    36

    2022.06.13

    衛食添新申字(2022)0036

    Ammonium glycyrrhizinate

    37

    2022.06.13

    衛食添新申字(2022)0037

    Acesulfame potassium

    38

    2022.06.20

    衛食添新申字(2022)0038

    Magnesium lactate

    39

    2022.06.28

    衛食添新申字(2022)0039

    Sodium acetate

    40

    2022.06.28

    衛食添新申字(2022)0040

    Fumaric acid

    41

    2022.07.04

    衛食添新申字(2022)0041

    Isomerized lactose

    42

    2022.07.04

    衛食添新申字(2022)0042

    Isomerized lactose

    43

    2022.07.06

    衛食添新申字(2022)0043

     Nucleotide

    44

    2022.07.11

    衛食添新申字(2022)0044

    Sucralose

    45

    2022.07.12

    衛食添新申字(2022)0045

    L-serine

    46

    2022.07.12

    衛食添新申字(2022)0046

    L-Aspartic acid

    47

    2022.07.12

    衛食添新申字(2022)0047

    L(-)-Proline

    48

    2022.07.12

    衛食添新申字(2022)0048

    L-lysine-l-glutamic acid dihydrate

    49

    2022.07.12

    衛食添新申字(2022)0049

    L-citrulline

    50

    2022.07.12

    衛食添新申字(2022)0050

    L-potassium glutamate monohydrate

    51

    2022.07.12

    衛食添新申字(2022)0051

     L-glutamic acid

    52

    2022.07.12

    衛食添新申字(2022)0052

     L-glutamine

    53

    2022.07.12

    衛食添新申字(2022)0053

     L-lysine-L-aspartic acid

    54

    2022.07.12

    衛食添新申字(2022)0054

     L-ornithine hydrochloride

    55

    2022.07.12

    衛食添新申字(2022)0055

     N-acetyl-L-cysteine

    56

    2022.07.12

    衛食添新申字(2022)0056

     Glycine

    57

    2022.07.12

    衛食添新申字(2022)0057

     L-lysine monohydrate

    58

    2022.07.12

    衛食添新申字(2022)0058

    L-calcium glutamate tetrahydrate

    59

    2022.07.12

    衛食添新申字(2022)0059

    L-magnesium aspartate dihydrate

    60

    2022.07.12

    衛食添新申字(2022)0060

    Sodium N-cyclohexyl sulfamate (Also called cyclamate)

    61

    2022.07.13

    衛食添新申字(2022)0061

    Potassium glycyrrhizinate

    62

    2022.07.13

    衛食添新申字(2022)0062

    Tripotassium glycyrrhizinate

    63

    2022.07.15

    衛食添新申字(2022)0063

    lysophospholipase

    64

    2022.07.15

    衛食添新申字(2022)0064

     Potassium hydrogen tartrate

    65

    2022.08.12

    衛食添新申字(2022)0065

    vitamin E

    66

    2022.08.17

    衛食添新申字(2022)0066

    gardenia yellow

    67

    2022.08.17

    衛食添新申字(2022)0067

    Riboflavin

    68

    2022.08.23

    衛食添新申字(2022)0068

    L- lysine

    69

    2022.08.30

    衛食添新申字(2022)0069

    Curdlan

    70

    2022.09.02

    衛食添新申字(2022)0070

    Mycelial fermentation of Cordyceps sinensis

    71

    2022.09.05

    衛食添新申字(2022)0071

    Vanillin (fermentation)

    72

    2022.09.14

    衛食添新申字(2022)0072

    Cellulase

    73

    2022.09.29

    衛食添新申字(2022)0073

    Tomato red

    74

    2022.10.26

    衛食添新申字(2022)0074

    Nisin

    75

    2022.10.31

    衛食添新申字(2022)0075

    Taurine

    76

    2022.10.31

    衛食添新申字(2022)0076

    Vitamin B1

    77

    2022.10.31

    衛食添新申字(2022)0077

    Vitamin B2

    78

    2022.11.01

    衛食添新申字(2022)0078

    Serine protease

    79

    2022.11.01

    衛食添新申字(2022)0079

    beta-galactosidase

    80

    2022.11.04

    衛食添新申字(2022)0080

    L-alanine

    81

    2022.11.04

    衛食添新申字(2022)0081

    Ascorbyl palmitate (enzymatic method)

    82

    2022.11.04

    衛食添新申字(2022)0082

    Ascorbyl palmitate (enzymatic method)

    83

    2022.11.11

    衛食添新申字(2022)0083

    Ethyl acetate

    84

    2022.11.11

    衛食添新申字(2022)0084

    Dichloromethane

    85

    2022.11.15

    衛食添新申字(2022)0085

    2’-fucosyllactose

    86

    2022.11.16

    衛食添新申字(2022)0086

    beta-glucanase

    87

    2022.11.29

    衛食添新申字(2022)0087

    Apple polyphenol

    88

    2022.11.29

    衛食添新申字(2022)0088

    hydroxytyrosol

    89

    2022.11.29

    衛食添新申字(2022)0089

    Monascus red

    90

    2022.12.06

    衛食添新申字(2022)0090

    Sanzan gum

    91

    2022.12.06

    衛食添新申字(2022)0091

    Sanzan gum

    92

    2022.12.06

    衛食添新申字(2022)0092

    Sanzan gum

    93

    2022.12.13

    衛食添新申字(2022)0093

    Sanzan gum

    94

    2022.12.19

    衛食添新申字(2022)0094

    Monascus yellow pigment

    95

    2022.12.19

    衛食添新申字(2022)0095

    sulfate

    96

    2022.12.20

    衛食添新申字(2022)0096

    Carnauba wax

    97

    2022.12.20

    衛食添新申字(2022)0097

    Bees wax

    2. List of new food additives issued for public comments in 2022 (45 types)

    In 2022, 45 new food additives passed the technical review of the CFSA and were issued for public comments, including 13 new food enzymes, three new food processing aids (including expanded use), one new flavor for food, 16 new nutrition enhancers, four existing nutrition enhancers with expanded use, one new food additive and seven existing food additives with expanded use.

    Among them, carmine cochineal, aminopeptidase, xylanase, carboxypeptidase, phospholipase A2, lactase (beta-galactosidase), and D-psicose 3-epimerase which were accepted in 2022, the other seven products applications were accepted by NHC in 2021.

    2.1 List of new food enzymes (13 types)

    No

    Name

    Source

    Donor

    Approval status (By the end of December 2022)

    1

    β-glucanase

    Bacillus subtilis

    Bacillus subtilis

    Accepted on September 17, 2022, 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.

    2

    Protease

    Bacillus subtilis

    Alkalihalobacillus clausii

    Its acceptance information could not be confirmed.

    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

    Trehalase

    Trichoderma reesei

    Trichoderma reesei

    Accepted on September 17, 2022, 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.

    4

    Lactase

    Aspergillus niger

    Aspergillus oryzae

    Accepted on November 9, 2022, Acceptance number: 衛食添新申字(2021)第0053號.

    Passed the technical review and issued for public comments on April 15, 2022, and officially approved on September 7, 2022, according to No. 5 of 2022.

    5

    Aminopeptidase

    Aspergillus oryza

    Aspergillus oryza

    Accepted on March 7, 2022, Acceptance number: 衛食添新申字(2022)第0010號.

    Passed the technical review and issued for public comments on July 1, 2022.

    It has not been officially approved.

    6

    Xylanase

    Bacillus licheniformis

    Bacillus licheniformis

    Accepted on March 7, 2022, Acceptance number:衛食添新申字(2022)第0009號.

    Passed the technical review and issued for public comments on July 1, 2022,

    It has not been officially approved.

    7

    Carboxypeptidase

    Aspergillus oryzae

    Aspergillus oryza

    Accepted on January 6, 2022, Acceptance number: 衛食添新申字(2022)第0001號.

    Passed the technical review and issued for public comments on July 1, 2022.

    It has not been officially approved.

    8

    Deaminase

    Aspergillus oryza

    -

    Accepted on April 30, 2020, Acceptance number: 衛食添新申字(2020)第0020號.

    Passed the technical review and issued for public comments on July 1, 2022.

    It has not been officially approved.

    9

    Protease

    Trichoderma reesei

    Malbranchea sulfurea

    Its acceptance information could not be confirmed.

    Passed the technical review and issued for public comments on October 28, 2022.

    It has not been officially approved.

    10

    Phospholipase A2

    Trichoderma reesei

    Aspergillus fumigatus

    Accepted on April 28, 2022, Acceptance number: 衛食添新申字(2022)第0017號.

    Passed the technical review and issued for public comments on October 28, 2022.

    It has not been officially approved.

    11

    Maltogenic amylase

    Saccharomyces cerevisiae

    Geobacillus stearothermophilus

    Its acceptance information could not be confirmed.

    Passed the technical review and issued for public comments on October 28, 2022.

    It has not been officially approved.

    12

    Lactase(beta-galactosidase)

    Papiliotrema

    terrestris

    -

    Accepted on April 26, 2022, Acceptance number: 衛食添新申字(2022)第0016號.

    Passed the technical review and issued for public comments on October 28, 2022.

    It has not been officially approved.

    13

    D-psicose 3-epimeras

    Bacillus subtil

    Ruminococcus sp. CAG55

    Accepted on June 2, 2022, Acceptance number: 衛食添新申字(2022)第0033號.

    Passed the technical review and issued for public comments on December 8, 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 and Enzyme" (GB 1886.174).

    2.2 List of new food processing aid (one type)

    No

    Name

    Function

    Food name/category

    Maximum level in grams per kilogram (g/kg)

    Approval Status

    (By the end of December 2022)

    1

    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 for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

    2.3 List of existing food processing aids with expanded use (two types)

    No

    Name

    Function

    Usage scope

    Approval Status

    (By the end of December 2022)

    1

    Polydimethyl siloxane and emulsion

    Antifoaming agent

    Collagen casings processing technology

    Its acceptance information could not be confirmed.

    Passed the technical review and issued for public comments on July 1, 2022.

    It has not been officially approved.

    2

    Magnesium stearate

    Lubricant, release agent, anti-sticking agent

    Effervescent tablet pressing process

    Accepted on February 16, 2022, Acceptance number: 衛食添新申字(2022)第0007號.

    Passed the technical review and issued for public comments on July 1, 2022.

    It has not been officially approved.

    2.4 List of new flavor (one type)

    No

    Name

    Function

    Food name/category

    Maximum level grams per liter (g/L)

    Approval Status

    (By the end of June 2022)

    1

    2-hexylpyridine

    flavoring

    Used in various foods after being formulated into flavors (Except for the food category in Table B1 of GB 2760-2014)

    Appropriate level as required in production

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

    Passed the technical review and issued for public comments on October 28, 2022.

    It has not been officially approved.

    2.5 List of new food nutrition enhancers (16 types)

    No

    Name

    Category number

    Food name/category

    Maximum level

    Approval Status

    (By the end of December 2022)

    1

    2'-

    fucosyllactose

    01.03.02

    Modified milk powder (limited to milk powder for children)

    0.7-2.4 g/L (Count as pure products. In terms of ready-to-eat state, for powdery products, the level of use should be increased by brewing time.) When mixed with Lacto-N-neotetraose, oligo-galactose, oligofructose, polyfructose and raffinose, the total amount of 2'-

    fucosyllactoseshall must not exceed 64.5 (g/kg)

    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.

    Passed the technical review and issued for public comments on April 15, 2022 and October 28, 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 purposes

    2

    L-alanine

    • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
    • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922.

    Accepted on March 3, 2022, Acceptance number: 衛食添新申字(2022)0008.

    Passed the technical review and issued for public comments on July 1, 2022.

    It has not been officially approved.

    3

    L-Arginine Hydrochloride

    • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
    • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922.

    Accepted on November 16, 2021, Acceptance number: 衛食添新申字(2021)第0055號.

    Passed the technical review and issued for public comments on July 1, 2022.

    It has not been officially approved.

    4

    L-selenomethyl selenocysteine

    The application range and dosage of L-Se-methyl selenocysteine are consistent with the provisions of selenium approved in GB14880 "National Food Safety Standard for the Use of Food Nutrition Enhancer".

    Accepted on June 13, 2022, Acceptance number: 衛食添新申字(2022)第0035號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    5

    L-Cysteine

    • 13.01.01 Infant formula: Execute with reference to GB 10765;
    • 13.01.02 Older infants and toddler formula (Older infants formula only): Execute with reference to GB 10766;
    • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
    • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0028號;

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    6

    L-Cysteine Hydrochloride Monohydrate

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0023號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    7

    L-cysteine hydrochloride

    • 13.01.01 Infant formula: Execute with reference to GB 10765;
    • 13.01.02 Older infants and toddler formula (Older infants formula only): Execute with reference to GB 10766;
    • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
    • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922.

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0027號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    8

    L-Cystine

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0022號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    9

    L-Histidine

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0025號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    10

    L-Histidine Hydrochloride Monohydrate

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0031號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    11

    L-Lysine Hydrochloride

    • 13.01.01 Infant formula: Execute with reference to GB 10765;
    • 13.01.02 Older infants and toddler formula (Older infants formula only): Execute with reference to GB 10766;
    • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
    • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0030號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    12

    L-Lysine acetate

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0024號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    13

    L-Phenylalanine

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0029號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    14

    L-Threonine

    Accepted on May 26, 2022, Acceptance number: 衛食添新申字(2022)第0026號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    15

    Lacto-N-neotetraose

    01.03.02

    Modified milk powder (limited to milk powder for children)

    0.2-0.6 g/L (Count as pure products – ready-to-eat state, for powdery products, the level of use should be increased by the brewing time) When mixed with 2’-FL , oligo-galactose, oligofructose, polyfructose and raffinose, the total amount of Lacto-N-neotetraose must not exceed 64.5 g/kg

    Accepted on October 18, 2021, Acceptance number: 衛食添新申字(2021)第0049號.

    Passed the technical review and issued for public comments on October 28, 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 purposes

    16

    Magnesium lactate

    The application range and dosage of magnesium lactate are consistent with the provisions of magnesium approved in GB14880 "National Food Safety Standard for the Use of Food Nutrition Enhancer".

    Accepted on June 20, 2022, Acceptance number: 衛食添新申字(2022)第0038號.

    Passed the technical review and issued for public comments on December 8, 2022.

    It has not been officially approved.

    2.6 List of food nutrition enhancers with expanded use (four types)

    No

    Name

    Category number

    Food name/category

    Maximum level

    Approval Status

    (By the end of December 2022)

    1

    Vitamin B1

    14.04.02.01

    beverages for special uses (including sports drinks and nutrient drinks.)

    2 mg/kg~5 mg/kg

    Accepted on October 31, 2022, Acceptance number: 衛食添新申字(2022)0076.

    Passed the technical review and issued for public comments on December 8, 2022.

    It has not been officially approved.

    2

    Vitamin B2

    14.04.02.01

    beverages for special uses (including sports drinks and nutrient drinks.)

    2 mg/kg~5 mg/kg

    Accepted on March 26, 2014, Acceptance number: 衛食添新申字(2014)第0013號;

    Passed the technical review and issued for public comments on December 8, 2022,

    It has not been officially approved.

    3

    Taurine

    14.04.02.01

    beverages for special uses (including sports drinks and nutrient drinks.)

    0.1 g/kg~0.6 g/kg

    Accepted on October 31, 2022, Acceptance number: 衛食添新申字(2022)0075.

    Passed the technical review and issued for public comments on December 8, 2022,

    It has not been officially approved.

    4

    Ascorbic palmitate (Enzymatic)

    The application range and dosage of ascorbic palmitate are consistent with the provisions of vitamin C approved in GB14880 "National Food Safety Standard for the Use of Food Nutrition Enhancer".

    Its acceptance information could not be confirmed.

    Passed the technical review and issued for public comments on December 8, 2022.

    It has not been officially approved.

    2.7 List of new food additive (1 type)

    No

    Name

    Function

    Category number

    Food name/category

    Maximum level

    Approval Status

    (By the end of December 2022)

    1

    Potassium Polyaspartate

    Stabilizer and coagulator

    15.03.01

    Wine

    0.3 g/L

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

    Passed the technical review and issued for public comments on December 28, 2022.

    It has not been officially approved.

    2.8 List of food additives with expanded use (seven types)

    No

    Name

    Function

    Category number

    Food name /category

    Maximum level (g/kg)

    Approval Status

    (By the end of December 2022)

    1

    Potassium acesulfame

    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.

    2

    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 for public comments on April 15, 2022, and officially approved on September 7, 2022, according to No. 5 of 2022.

    3

    Fumaric acid

    Acidity regulator

    08.02.02 Cured meat product (brined meat, preserved pork, preserved duck, Chinese-style ham, and Chinese sausage)

    08.03.02 Smoked, baked, or grilled meat

    08.03.03 Fried meat

    08.03.05 Meat enema

    09.02.02 Frozen coated seafood product

    09.04.02 Cooked or fried seafood product

    09.04.03 Smoked or grilled seafood product

    Appropriate level as required in production

    Accepted on June 28, 2022, Acceptance number: 衛食添新申字(2022)第0040號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    4

    Sodium acetate

    Accepted on June 28, 2022, Acceptance number: 衛食添新申字(2022)第0039號.

    Passed the technical review and issued for public comments on August 19, 2022.

    It has not been officially approved.

    5

    Sodium N-cyclohexyl sulfamate (Also called cyclamate)

    Sweetener

    07.04

    Fillings and topping syrups for bakeries (fillings of crackers only)

    2.0 (In terms of cyclohexyl sulfamic acid)

    Accepted on July 12, 2022, Acceptance number: 衛食添新申字(2022)第0060號.

    Passed the technical review and issued for public comments on October 28, 2022.

    It has not been officially approved.

    16.06

    Puffed food

    0.2 (In terms of cyclohexyl sulfamic acid)

    6

    Vitamin E

    Antioxidant

    06.03.02.04

    Batters (e.g.  batters for fish or poultry), breaded, frying

    powder

    0.2

    Its acceptance information could not be confirmed.

    Passed the technical review and issued for public comments on October 28, 2022.

    It has not been officially approved.

    7

    Ascorbic palmitate (Enzymatic)

    Antioxidant

    06.07

    Instant wheat or rice product

    0.2

    Its acceptance information could not be confirmed.

    Passed the technical review and issued for public comments on October 28, 2022.

    It has not been officially approved.

    3. List of approved new food additives in 2022 (32 types)

    In 2022, 32 types of new food additives were approved by the NHC, which includes 13 new enzymes for the food industry, one new food additive, one new processing aid, one new food nutrition enhancer, 13 existing food additives with expended use, and three processing aids with expanded use. The relevant information is as follows:

    3.1 List of approved new food enzymes (13 types)

    No

    Name

    Source

    Donor

    Acceptance information, public comment, and approval announcements

    (By the end of December 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 for 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 for 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 for 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 for 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 for 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

    Its acceptance information could not be confirmed.

    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 for 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 for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

    13

    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 for public comments on April 15, 2022, and officially approved on September 7, 2022, according to No. 5 of 2022.

    Note: the quality specifications of enzyme preparations for the food industry should meet the provisions of the National Standard for Food Safety, Food Additives, and enzyme preparations for Food Industry (GB1886.174).

    3.2 List of new food additives (one type)

    No

    Name

    Function

    Category number

    Food name/category

    Maximum level (g/kg)

    Acceptance information, public comment, and approval announcements

    (By the end of December 2022)

    1

    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 for 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 aids (one type)

    No

    Name

    Function

    Usage scope

    Maximum level (g/kg)

    Acceptance information, public comment, and approval announcements

    (By the end of December 2022)

    1

    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 (one type)

    No

    Name

    Function

    Category number

    Food name/category

    Maximum level (mg/kg)

    Acceptance information, public comment, and approval announcements

    (By the end of December 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 for 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)

    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 (13 types)

    No

    Name

    Function

    Category number

    Food Name/ Category

    Maximum level (g/kg)

    Acceptance information, public comment, and approval announcements

    (By the end of December 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 for 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)0025.

    Passed the technical review and issued for 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

    Flour pastes (e.g., drag flour pastes used for fish, and poultry), breading and frying flour

    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 for 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 for 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 (including puffed soy protein food and soybean meat, )

    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 for 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 for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

    04.01.02.05

    Jam

    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 for public comments on April 12, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

    01.06.01

    Unripened cheese

    8

    Magnesium chloride

    Flavoring agent

    06.07

    Instant rice and flour products

    Appropriate level

    Accepted on September 11, 2021, Acceptance number: 衛食添新申字(2020)第0057號.

    Passed the technical review and issued for 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

    Processed 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 for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

    01.02.02

    Flavored fermented milk

    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.

    12

    Tomato red

    Colorant

    09.02.03

    Frozen surimi and its products (including fish balls)

    0.08 (Measured as Lycopene)

    Accepted on September 22, 2021, Acceptance number: 衛食添新申字(2021)第0044號.

    Passed the technical review and issued for public comments on December 8, 2021, and officially approved on September 7, 2022, according to No. 5 of 2022.

    09.04

    Cooked aquatic products (Can be directly consumed)

    13

    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 for public comments on April 15, 2022, and officially approved on September 7, 2022, according to No. 5 of 2022.

    2.6 List of approved processing aids with expanded use (three types)

    No

    Name

    Function

    Usage scope

    Acceptance information, public comment, and approval announcements

    (By the end of December 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 for 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 for 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, counts 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

    The 2'-fucosyl lactose (2’FL) from modified E-coli was released for public comments by CFSA on April 15, 2022, which was a big step forward for the application of genetically modified microorganisms (GMM) food additives in China, and it can be expected that 2’-FL will get the approval in China soon. New food enzymes account for almost 1/3 of the food additives reviewed and approved in 2022, and most of the food enzymes are genetically modified. On December 8, 2022, the CFSA publicly solicited opinions on D-psicose-3-epimerase, whose donor bacteria were specific to the strain number.

    Furthermore, it can be found that the registration period for some products is quite short. For example, it only takes about six months for glucose oxidase to receive the final approval for its acceptance by the NHC, which can be seen that if the application dossiers are well-prepared, the product can pass the technical review once and receive the final approval quickly. So, it is suggested that the applicant pays 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 need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

      

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