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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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