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    NHC Newly Approved 5 New Food Raw Materials, 9 New Food Additives, and 6 Food-related Products

    from CIRS by

    On July 2, 2025, National Health Commission of the People’s Republic of China (NHC) issued an announcement (No. 4 of 2025) for “Three New Foods” with 20 products approved, including 5 new food raw materials, 9 new food additives, and 6 food-related products.

    China,Food,Additive,Raw,Material,Approve,Registration

    Details are as follows:

    New food raw materials

    D-allulose/D-psicose

    Name

    D-allulose/D-psicose

    Basic information

    Structure:

    CAS No.: 551-68-8

    Molecular formua: C6H12O6

    Molar mass:180.16

    Brief introduction of production process

    Method One involves using glucose or sucrose as raw materials, which are then fermented, purified, and dried using E. coli AS10.

    Method Two uses fructose as the raw material, which is catalyzed by the permitted D-psicose 3-epimerase, followed by processes of decolorization, separation, purification, and crystallization.

    Recommended intake

    ≤ 20 g/day

    Other information

    • Not suitable for infants, pregnant women, and lactating women. Labels and instructions must indicate unsuitable populations and consumption limits.
    • Quality specifications and food safety indicators are listed in the appendix.

    Saccharomyces cerevisiae CNCM I-3799

    Name

    Saccharomyces cerevisiae CNCM I-3799

    Other information

    • The strain is approved and included in the List of Microorganisms That Can Be Used in Food, with the exception that it is not permitted for use in infant and young children’s food.
    • The food safety indicators shall comply with the requirements of the National Food Safety Standard for Microbial Preparations Used in Food Processing (GB 31639).

    Bifidobacterium animalis subsp.lactis BLa80

    Name

    Bifidobacterium animalis subsp.lactis BLa80

    Other information

    • The strain is approved and included in the List of Microorganisms That Can Be Used in Food, with the exception that it is not permitted for use in infant and young children’s food.
    • The food safety indicators shall comply with the requirements of the National Food Safety Standard for Microbial Preparations Used in Food Processing (GB 31639). Cronobacter spp. must not be detected (per 100 g).

    Bifidobacterium longum subsp. infantis LMG 11588

    Name

    Bifidobacterium longum subsp. infantis LMG11588

    Other information

    • The strain is approved and included in the List of Microorganisms That Can Be Used in Food, with the exception that it is not permitted for use in infant and young children’s food.
    • The food safety indicators shall comply with the requirements of the National Food Safety Standard for Microbial Preparations Used in Food Processing (GB 31639). Cronobacter spp. must not be detected (per 100 g).

    Sodium hyaluronate (extract)

    Name

    Sodium hyaluronate (extract)

    Basic information

    Chicken comb from Gallus gallus domesticus

    Brief introduction of production process

    The product is manufactured from the combs of Gallus gallus domesticus through a series of processes including chopping, enzymatic hydrolysis, filtration, concentration, purification, drying, and milling.

    Recommended intake

    ≤ 300 mg/day

    Specifications

    Properties

    White powder

    Sodium hyaluronate, g/100g

    ≥60.0

    Chondroitin sulfate, g/100g

    ≥5.0

    Collagen, g/100g

    ≥5.0

    Moisture, g/100g

    ≤10.0

    Ash, g/100g

    ≤15.0

    PH

    6.0~8.0

    Other information

    1.Scope of use: Dairy and dairy products: 0.3 g/kg for formulated milk and flavored fermented milk; for milk powder and its formulated products, the amount is calculated based on the reconstituted liquid mass.

    Beverages: For liquid beverages packaged in containers of ≤50 mL, up to 3.0 g/kg; for packaging between 51 mL and 500 mL, up to 0.3 g/kg; for solid beverages, the amount is calculated based on the reconstituted liquid mass.

    Alcoholic beverages: 1.5 g/kg.

    Cocoa products, chocolate and chocolate products (including compound chocolate and related products) and confectionery: 4.5 g/kg.

    Frozen desserts: 3.0 g/kg.

    2.Not suitable for infants, pregnant women, and lactating women. Labels and instructions must indicate unsuitable populations and consumption limits.

    3.Quality specifications and food safety indicators are listed as follow.

    Pb, mg/kg

    ≤0.5

    Cd

    ≤0.5

    Hg

    ≤0.05

    As, mg/kg

    ≤0.3

    Cr, mg/kg

    ≤5.0

    Total colony count

    ≤1000

    Coliform bacteria

    ≤50

    Molds and yeasts

    ≤150

    Salmonella

    Not detected

    Staphylococcus aureus

    Not detected

    New food additives (9 types)

    New food enzymes

    No.

    Enzyme

    Source

    Donor

    1

    Aminopeptidase

    Trichoderma reesei

    Aspergillus clavatus

    2

    Xylanase

    Trichoderma reesei

    Fusariumverticillioides

    3

    Glucoamylase

    Aspergillus niger

    Trametescingulata

    The quality specifications for enzymes used in the food industry shall comply with the provisions outlined in the National Food Safety Standard for Food Additives – Enzymes for Food Industry (GB 1886.174).

    New food additives with expanded scope

    No.

    Name

    Function

    Category number

    Food name

    Maximum level (g/kg)

    Note

    1

    Ascorbyl palmitate (enzymatic method)

    Antioxidant

    13.01

    Infant formula

    0.05

    Calculated as ascorbic acid in the oil/fat

    13.02

    Infant complementary foods

    0.05

    Calculated as ascorbic acid in the oil/fat

    Processing aids with expanded scope

    No.

    Name

    Function

    Application scope

    1

    sulfuric acid

    wall breaking

    Algal cell wall breaking technology

    2

    deacetylated chitin (chitosan)

    clarifying agent

    Sugar production process

    3

    ethyl acetate

    extraction solvent

    Processing method for oil derived from algae (residual solvent/content ≤ 20 mg/kg)

    Food additives with supplementary quality specification

    2’-fucosyllactose,2’-FL

    Application scope, usage level and specifications: The application scope and specification for 2'-Fucosyllactose shall follow the Notice No. 8 of 2023 issued by the National Health Commission (except for the information on the production strains used for 2'-Fucosyllactose production in Appendix C). The information on the production strains for this new nutrition enhancer is provided in the table below.

    Nutrition enhancer

    Source

    Donor

    2’-fucosyllactose

    Bacillus subtilis 168

    Bacillussubtilisa

    Escherichia colib

    Helicobacter pylori.c

    Escherichia coli

    BL21(DE3)

    Helicobacter pylori.c

    Escherichia coli O126c

    Escherichia coli K- 12 MG1655

    Helicobacter pylori.c

    a donor for mannose-6-phosphate isomerase

    b donor for phosphomannomutase, mannose-1-phosphate guanylyltransferase, GDP-mannose dehydratase, GDP-fucosyltransferase, lactose permease, and sugar efflux transporter

    c donor for α-1, 2-fucosyltransferase

    Food additives subject to changes in quality specification

    Quality Specification Requirements of Food Additive Magnesium L-sulfate as Stipulated in the 2016 Announcement No. 8 by the Former National Health and Family Planning Commission:

    Name

    Index

    Test method

    Mg, mg/kg

    7.2-8.3

    GB5413.21

    Changed into

    Name

    Index

    Test method

    Mg, w%

    7.2-8.3

    GB5413.21

    New food-related products (6 types)

    Food contact additives with expanded use scope/level

    Name

    CAS number

    Range of application

    Maximum level

    Ammonium salt of dodecanoic acid

    2437-23-2

    Coatings and paints

    0.6

    Hexanedioic acid, polymer with2- ethyl-2-(hydroxymethyl)-1,3- propanediol

    28301-90-8

    Coatings and paints

    3

    3-Aminopropyltriethoxysilane

    919-30-2

    Plastic: Unsaturated Polyester Resin (UP)

    0.01125

    Bis(2-ethylhexyl) adipate

    103-23-1

    Plastic: Polyvinylidene Fluoride (PVDF)

    35

    Esters of C12~C18 straight chainfattyacids and C12~C18 straight chainfattyalcohols

    Plastic

    0.5

    New food contact resin

    Name

    CAS number

    Range of application

    Maximum level

    1,3-Benzenedicarboxylic acid, polymer with

    1,4-benzenedicarboxylic acid, 1,4-butanediol, 1,4-cyclohexanedimethanol, 1,3- dihydro- 1,3-dioxo-5-isobenzofurancarboxylicacid and 1,2-ethanediol

    1621282-90-3

    Coatings and paints

    30

    About CIRS Group

    Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 domestic and international food companies achieve one-stop compliance solutions. CIRS offers a full range of regulatory services covering novel food applications, synthetic biology-derived foods, U.S. GRAS notice, EU novel food application, health food registration, and food for special medical purposes (FSMP).

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