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

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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

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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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