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    Analysis on the Registration Application of New Food Raw Material (Novel Food) in China in 2022

    from CIRS by

    China,Food,Novel,Three,New,Raw,Material,Registration

    In 2022, the National Health Commission of the People's Republic of China (NHC) issued 3 announcements for “Three New Foods” (No.1, 2022; No.2, 2022; No.5, 2022), with 75 products approved (including new food raw materials, new food additives and products related to food). Among the 75 products, five new food raw materials were approved, these are:

    • Kanzan flower,
    • Pyrroloquinolinequinonedisodium (PQQ) salt,
    • Chlamydomonas reinhardtii,
    • Bifidobacterium longum subsp.longum BB536, and
    • Sugarcane Polyphenols.

    In addition, according to the List for the Products on Termination of Review issued by NHC, the approval process for three raw materials were terminated in 2022, these are:

    • Penthorum chinense Pursh,
    • Sialic acid, and
    • Gua Lou Zi.

    According to the statistics from the NHC and the China National Center for Food Safety Risk Assessment (CFSA), a total of 22 new food raw materials applications were accepted in 2022, three public consultations on new food raw materials were released. Furthermore, four substances accepted in 2019/2021/2022 were rejected for approval in 2022.

    This article will provide you with more information about the acceptance and approval status of new food raw materials in China in 2022.

    1. List of new food raw material applications accepted in 2022 (22 types)

    In 2022, the NHC accepted 22 applications for new food raw materials, including 16 domestic products and 6 imported products. The technical review status is shown in the following table.

    S/N

    Acceptance Date

    Acceptance Number

    Name

    The technical review status

    1

    17/01/2022

    衛食新申字(2022)0001

    Penthorum chinense Pursh

    Be included in the termination review list

    2

    17/03/2022

    衛食新申字(2022)0002

    (3R, 3'S) -dihydroxy-β-

    carotene

    Not yet issue for public comments

    3

    29/03/2022

    衛食新進申字(2022)0001

    Maquiberry Extract

    Not yet issue for public comments

    4

    24/04/2022

    衛食新申字(2022)0003

    Gua Lou Zi

    Be included in the termination review list

    5

    07/05/2022

    衛食新申字(2022)0004

    Peach gum

    Not yet issue for public comments

    6

    23/05/2022

    衛食新申字(2022)0005

    Pinus massoniana Lamb.

    Rejected

    7

    06/06/2022

    衛食新申字(2022)0006

    Corolla leaf

    Not yet issue for public comments

    8

    09/06/2022

    衛食新申字(2022)0007

    Brown Sugar Oligofructose

    Not yet issue for public comments

    9

    26/07/2022

    衛食新申字(2022)0008

    Yeast protein

    Not yet issue for public comments

    10

    11/08/2022

    衛食新申字(2022)0009

    Periploca sepium Bunge leaves

    Rejected

    11

    12/08/2022

    衛食新進申字(2022)0002

    D-Psicose/D-Allulose

    Not yet issue for public comments

    12

    05/09/2022

    衛食新申字(2022)0010

    Cyperus esculentus var. sativus Boeckeler

    Not yet issue for public comments

    13

    14/09/2022

    衛食新進申字(2022)0003

    Cherry Blossom Extract

    Not yet issue for public comments

    14

    19/09/2022

    衛食新申字(2022)0011

    Bifidobacterium lactis BLa80

    Not yet issue for public comments

    15

    17/10/2022

    衛食新申字(2022)0012

    D-allulose

    Not yet issue for public comments

    16

    02/11/2022

    衛食新進申字(2022)0004

    Yerba mate

    Not yet issue for public comments

    17

    10/11/2022

    衛食新進申字(2022)0005

    Peanut membrane extract

    Not yet issue for public comments

    18

    21/11/2022

    衛食新申字(2022)0013

    D-allulose

    Not yet issue for public comments

    19

    05/12/2022

    食新進申字(2022)0006

    Pichia kluyveri

    Not yet issue for public comments

    20

    12/12/2022

    衛食新申字(2022)0014

    Bifidobacterium animalis subsp.lactis CP-9

    Not yet issue for public comments

    21

    19/12/2022

    衛食新申字(2022)0015

    N-Acetylneuraminic acid

    Not yet issue for public comments

    22

    20/12/2022

    衛食新申字(2022)0016

    γ-Aminobutyric acid

    Not yet issue for public comments

    2. List of new food raw materials for public comments released by CFSA in 2022 (three types)

    In 2022, a total of three new food raw materials passed the technical review of the expert review committee and solicited public opinions, none of which have been formally approved yet.

    (1) Arabinoxylan (Draft announcement):

    Name

    Arabinoxylan

    Basic information

    Structure: arabinoxylan structure (fragment)

    CAS number: 9040-27-1

    Brief introduction of the production process

    Prepared through pretreatment, edible alkali extraction, desalkali concentration, neutralization precipitation, washing and purification, drying, and other processes by using sugarcane, wheat bran, corn skin, and other grains as raw materials.

    Recommended intake

    ≤15 grams per day (g/day) (with arabinoxylan content of 85 g/100 g, the content exceeding the actual content shall be converted)

    Other information

    1. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions.

    2. Quality specifications and food safety indicators are detailed in the draft announcement.

    Issued date

    14/03/2022

    CFSA Collected Public Comments on Arabinoxylan

    (2) Leuconostoc pseudomesenteroides (Draft announcement):

    Latin Name

    Leuconostoc pseudomesenteroides

    Other information

    1. Scope of use: fermented milk, cheese, fermented milk-containing drinks, and lactic acid bacteria drinks.

    2. Approved as edible fungi, the scope of use does not include infant food.

    3. Food safety indicators should meet the relevant standards of China.

    Issued date

    29/06/2022

    CFSA Collected Public Comments on Leuconostoc pseudomesenteroides

    Acceptance date

    19/04/2021, 衛食新進申字(2021)第0002號

    (3) Calcium alciumnce damethyl butyrate (CaHMB) (Draft announcement):

    Name

    Calcium β-hydroxy-β-methyl butyrate (CaHMB)

    Basic information

    Constitutional formula:

    Molecular formula: C10H18O6Ca?H2O

    Molecular weight: 292

    Brief introduction of the production process

    Prepared through oxidation synthesis, acidification, extraction, neutralization reaction, centrifugation, drying, and other processes by using sodium hypochlorite, diacetonol, hydrochloric acid, ethyl acetate, ethanol, calcium hydroxide as the main raw materials.

    Recommended intake

    ≤ 6 g/day

    Other information

    1. Scope of use: beverages, milk, and dairy products, cocoa products, chocolate and chocolate products, confectionery, baked goods, sports nutrition food, and formula food for special medical use.

    2. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions with consumption limits.

    3. See the draft announcement for quality specifications and food safety indicators.

    Issued date

    21/10/2022

    CFSA Collected Public Comments on Calcium β-hydroxy-β-methyl butyrate (CaHMB)

    Acceptance date

    15/06/2020, 衛食新申字(2020)第0003號

    3. List of approved new food raw materials in 2022 (five types)

    In 2022, the NHC approved a total of five new food raw materials, and the details are as follows:

    (1) Kanzan flower

    Name

    Kanzan flower

    Basic information

    Source: The flowers of Cerasus serrulata ”Sekiyama". The flowering period is more than 3/4 of the buds to full bloom.

    Other information

    1. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions.

    2. Food safety indicators shall be implemented in accordance with the provisions of other vegetable products.

    Acceptance date

    25/01/2021, 衛食新申字(2021)第0001號

    Date of soliciting comment

    17/08/2021

    CFSA Collected Public Comments on Kanzan flower and Pyrroloquinolinequinonedisodium (PQQ) salt

    Approved date

    01/03/2022, officially approved by the announcement No.1 of 2022

    (2) Pyrroloquinolinequinonedisodium (PQQ) salt

    Name

    Pyrroloquinolinequinonedisodium (PQQ) salt

    Basic information

    CAS: 122628-50-6

    The formula is: C14H4N2Na2O8

    Molecular weight: 374.17

    Chemical structural formula:

    Brief introduction of the production process

    Prepared through coupling ring formation reaction, quinoline ring formation, oxidation reaction and ester hydrolysis reaction, refining, and other processes by using 6-amino-5-methoxy-1H-Indo-2-carboxyl ester and 2-oxidized prenenyl dimethyl ester as the main raw materials.

    Recommended intake

    ≤20 mg/day

    Quality requirement

    Shape and properties

    Red-brown powder

    Priroroquinone (dry base), g/100 g                                   ≥

    98.0

    Moisture, g/100 g                                                              ≤

    12.0

    Other information

    1. Scope and maximum use: beverage (40 mg/kg, solid beverage is converted according to the liquid volume after preparation).

    2. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions.

    3. The method for the determination of the content of pyrroloquinoline quinonedi sodium salt and two impurities (3-chloro-4,5-dioxo-4,5-dihydro-1H-pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid and 4-nitro-5-methoxy-1H-pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid) is described in the bulletin.

    4. Food safety indicators shall comply with the following provisions:

    Lead (Pb), mg/kg                                                              ≤

    0.5

    Arsenic (As), mg/kg                                                          ≤

    1.0

    Cadmium (Cd), mg/kg                                                      ≤

    0.1

    Mercury (Hg), mg/kg                                                        ≤

    0.1

    3-Chloro-4,5-dioxo-4,5-dihydro-1H-pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid, g/100g                                             ≤

    0.8

    4-Nitro-5-methoxy-1H-pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid, g/100g                                                                 ≤

    0.5

    Acceptance date

    08/03/2021, 衛食新申字(2021)第0004號

    Issued date

    17/08/2021

    CFSA Collected Public Comments on Kanzan flower and Pyrroloquinolinequinonedisodium (PQQ) salt

    Approved date

    01/03/2022, officially approved by the announcement .1 of 2022

    (3) Chlamydomonas reinhardtii

    Latin Name

    Chlamydomonas reinhardtii

    Basic information

    Species: Chlamydomonas family, Chlamydomonas

    Brief introduction of the production process

    Made by algal species cultivation, fermentation tank heterotrophic expansion cultivation, drying, and other processes.

    Quality requirement

    Shape and properties

    Green powder

    Protein content

    ≥30.0%

    Crude polysaccharide content

    ≥10.0%

    Other information

    1. The scope of use does not include infant food.

    2. Food safety indicators shall be implemented in accordance with the current national food safety standard on algae and algae products.

    Acceptance date

    13/09/2021, 衛食新申字(2021)第0011號

    Issued date

    08/12/2021

    CFSA Collected Public Comments on Chlamydomonas reinhardtii

    Approved date

    11/05/2022, officially approved by the announcement No.2 of 2022

    (4) Bifidobacterium longum subsp .longum BB536

    Latin Name

    Bifidobacterium longum subsp .longum BB536

    Other information

    1. Approved for use in infant food.

    2. Food safety indicators should meet the relevant standards of China.

    Acceptance date

    18/05/2021 , 衛食新進申字(2021)第0003號

    Issued date

    01/11/2021

    CFSA Collected Public Comments on Bifidobacterium longum subsp .longum BB536

    Approved date

    11/05/2022, officially approved by the announcement No.2 of 2022

    (5) Sugarcane polyphenols

    Name

    Sugarcane Polyphenols

    Brief introduction of the production process

    Prepared by using sugarcane as raw material through crushing, filtration, extraction, removing excess sugar and salt, using water and ethanol as an extraction solvent to be transferred into powder by filtration, vacuum concentration, ion exchange, spray drying, and other processes; or to be transferred into liquid by filtration, vacuum distillation, and other processes.

    Recommended intake

    ≤ 1 g/day (powder); ≤ 10 g/day (liquid)

    The recommended amount of powder (polyphenol content: 200 g/kg) is 1 g/day, and that of liquid (polyphenol content: 14.8 g/kg) is 10 g/day. When the polyphenol content exceeds the above, it shall be converted according to the actual content.

    Other information

    1. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions.

    2. Quality specifications and food safety indicators are detailed in the announcement.

    Acceptance date

    18/05/2021, 衛食新申字(2021)第0008號,

    Name of acceptance: Sugarcane Extract

    Issued date

    01/11/2021

    CFSA Collected Public Comments on Bifidobacterium longum subsp .longum BB536

    Approved date

    11/05/2022 officially approved, the announcement is No.2 of 2022

    4. List of terminated reviewed products in 2022 (3 types)

    In 2022, a total of three new food raw materials were included in the termination review list which contains 68 products at present. For the enterprises applying for new food raw materials, getting the review results of "ordinary food", "substantial equivalent" and "local traditional eating habits" is also a way to "get approval". The relevant termination review opinions are as follows.

    S/N

    Product Name

    Review Opinions

    Acceptance Date and Number

    1

    Penthorum chinense Pursh

    The NHC has approved penthorum chinense pursh as a new food raw material for bubble drinking in Announcement No.4 of 2020, and the application scope is applying for expanding to the beverage. Based on the safety assessment data provided, it was agreed to use the beverage and recommended to terminate the review. Except for the edible form, it shall be implemented in accordance with No.4 of 2020.

    17/01/2022, 衛食新申字(2022)第0001號

    2

    Gua Lou Zi

    Gua Lou Zi has been included in the "National Food Safety Standard Nuts and Seed Food" GB 19300, used as food raw materials according to the management of nuts and seed food, it was recommended to terminate the review.

    24/04/2022, 衛食新申字(2022)第0003號

    3

    Sialic acid

    Prepared through bacterial fermentation, filtration, sterilization, hydrolysis, ultrafiltration, decolorization, decontamination, nanofiltration, concentration, purification, drying, crushing, sieving, and other processes by Escherichia coli (strain No. CASOV-09) as the fermenting strain. The production process is essentially the same as that of Sialic acid approved for the announcement (formerly Health and Welfare Commission Announcement No. 7 of 2017), which shows substantial equivalence. Other requirements are implemented in accordance with the relevant content of the published announcement of Sialic Acid, and food safety indicators are implemented in accordance with the following: Aflatoxin B1≤5 micrograms per kilogram (μg/kg), Lead (calculated as Pb) ≤0.8 milligrams per kilogram (mg/kg), Mercury (calculated as Hg)≤0.2 mg/kg, Arsenic (calculated as As)≤0.4 mg/kg, total colony count ≤1000 CFU/g, Coliform ≤0.6 MPN/g, Mould≤100 CFU/g, Yeast≤100 CFU/g, Salmonella 0/25 g, Staphylococcus aureus 0/25 g.

    06/04/2021, 衛食新申字(2021)第0007號

    5. List of new food raw materials not approved and issued an administrative license by NHC in 2022 (three types)

    According to the publicly available information of NHC, there are four new food raw materials not approved and issued an administrative license in 2022,  including one product that submitted its application in 2019, two products in 2021, and one product in 2022. The details of each product are shown in the following table.

    S/N

    Product Name

    Acceptance Date

    Acceptance Number

    Review Process / Conclusion

    1

    Mycelium Oxalicum Powder

    The acceptance date was not reached

    衛食新進申字(2019)第0002號

    18/02/2022 Issuance of a decision not to grant administrative permission

    2

    Isomaltodextrin

    12/04/2021

    衛食新進申字(2021)第0001號

    01/06/2021 Delivering a notification of review opinion on the new food raw material

    22/04/2022 Issuance of a decision not to grant administrative permission

    3

    Maize ferments

    19/07/2021

    衛食新進申字(2021)第0004號

    30/07/2021 Delivering a notice on delaying review for the new food raw material

    08/10/2021 Delivering a notice on delaying review for the new food raw material

    02/12/2021 Delivering a notice on delaying review for the new food raw material

    17/02/2022 Delivering a notice on delaying review for the new food raw material

    26/04/2022 Issuance of a decision not to grant administrative permission

    4

    Pine (Pinus massoniana Lamb.) needle

    23/05/2022

    衛食新申字(2022)0005

    27/06/2022 Delivering a notification of review opinion on the new food raw material

    26/10/2022 Issuance of a decision not to grant administrative permission

    Summary

    Seeing that the Pyrroloquinolinequinonedisodium (PQQ) salt and Sugarcane Polyphenols were approved within one year and kept arousing discussions, the new food raw materials with certain functions or benefits are showing their superiority in the declaration of compliance and the food industry. For more details, please refer to the article New food raw materials are providing new vitality for the functional food industry by CIRS.

    On August 25, 2022, the NHC issued an announcement on the update of List of Strains that Can be Used in Food and List of Strains that Can be Used for Infants and Children (No.4, 2022). The classification and nomenclature of the strains involved in the two lists will be adjusted and a two-year transitional period will be set. According to the official interpretation, both the old and new strain names can be used during the transitional period, after which only the updated lists of strains can be used.

    As one of the "three new foods", new food raw materials (novel food) have the most complex and stringent requirements in declaration and review. Enterprises planning to carry out an application should set out early with adequate preparations of dossiers.

    If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

    (Note: There may be omissions and errors in the data statistics process because of the change of the official website. The data in this article is for reference only. Please refer to the official information published by the government.)

      

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