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    NHC Newly Approved 5 New Food Raw Materials, 8 New Food Additives, and 7 Food-related Products

    from CIRS by

    On February 10, 2025, National Health Commission of the Peoples Republic of China (NHC) issued an announcement (No. 1 of 2025) for “Three New Foods” with 20 products approved:

    • five new food raw materials;
    • eight new food additives; and
    • seven food-related products.

    China,Food,Approval,Additive,Ingredient,Food-related

    Details are as follows:

    New food raw materials

    Stevia polyphenols

    Name

    Stevia polyphenols

    Basic information

    Source: leaves of stevia polyphenols

    Brief introduction of the production process

    Made from the leaves of stevia polyphenols through processes such as ethanol extraction, filtration, purification, concentration, and drying.

    Recommended intake

    ≤500 mg/day

    Other information

    1. Scope of use and maximum use level:

    - Milk and dairy products: modified milk and flavored fermented milk 0.5 g/kg; modified milk powder is calculated based on the reconstituted liquid mass; cheese, processed cheese, cheese products, and condensed milk are calculated based on the multiple of raw milk.

    - Beverages: liquid beverages ≤50 mL packaging: 5 g/kg; 51-500 mL packaging: 0.5 g/kg; solid beverages are calculated based on the reconstituted liquid mass.

    - Jelly: 8 g/kg.

    - Cocoa products, chocolate, and chocolate products (including cocoa butter substitutes and products): 8 g/kg.

    - Candies: 25 g/kg.

    - Frozen desserts: 5 g/kg.

    - Alcoholic beverages: 2.5 g/kg.

    - Preserved fruits: 5 g/kg.

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

    3. Quality specifications and food safety indicators are listed in the appendix.

    Lemon myrtle leaf

    Name

    Lemon myrtle leaf

    Basic information

    Source: leaves of Backhousia citriodora F. Muell.

    Brief introduction of the production process

    Made from the leaves of Backhousia citriodora F. Muell. through processes such as picking, sorting, cleaning, and drying.

    Other information

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

    2. Food safety indicators are listed as follows.

    Pb, mg/kg

    ≤1.0

    Cd, mg/kg

    ≤0.5

    As, mg/kg

    ≤0.5

    Maqui berry anthocyanins

    Name

    Maqui berry anthocyanins

    Basic information

    Source: fruits of aristoteliachilensis

    Brief introduction of the production process

    Made from the fruits of aristoteliachilensis through processes such as extraction, filtration, purification, concentration, and drying.

    Recommended intake

    ≤900 mg/day

    Other information

    1. Scope of use and maximum use level:

    - Milk and dairy products: modified milk and flavored fermented milk 0.8 g/kg; modified milk powder is calculated based on the reconstituted liquid mass.

    - Beverages: liquid beverages ≤50 mL packaging: 8 g/kg; 51-500 mL packaging: 0.8 g/kg; solid beverages are calculated based on the reconstituted liquid mass.

    - Jelly: 14 g/kg.

    - Cocoa products, chocolate, and chocolate products (including cocoa butter substitutes and products): 14 g/kg.

    - Candies: 40 g/kg.

    - Frozen desserts: 8 g/kg.

    - Baked food: 4 g/kg.

    - Alcoholic beverages: 4 g/kg.

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

    3. Quality specifications and food safety indicators are listed in the appendix.

    Wheat polar lipids

    Name

    Wheat polar lipids

    Brief introduction of the production process

    Made from wheat flour through processes such as ethanol extraction, acetone precipitation, separation, drying, and grinding.

    Recommended intake

    ≤30 mg/day (calculated based on a digalactosyldiacylglycerol content of 40g/100g. If the content exceeds this amount, it will be converted according to the actual content.)

    Other information

    1. Scope of use and maximum use level:

    - Beverages: liquid beverages ≤50 mL packaging: 0.6 g/kg; 51-500 mL packaging: 0.06 g/kg; solid beverages are calculated based on the reconstituted liquid mass.

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

    3. Quality specifications and food safety indicators are listed in the appendix.

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

    Name

    Maqui berry anthocyanins

    Basic information

    Structure:

    Molecular formula: C10H18O6Ca?H2O

    Molar mass: 292

    Brief introduction of the production process

    Made from sodium hypochlorite, diacetone alcohol, hydrochloric acid, ethyl acetate, ethanol, and calcium hydroxide as the main raw materials, through processes such as oxidation synthesis, acidification, extraction, neutralization reaction, centrifugation, and drying.

    Recommended intake

    ≤6 mg/day

    Specifications

    Properties

    White powder

    Β-hydroxy-hydrazine-methylbutyric acid, g/100g

    77-82(test method in Appendix A)

    Ca, g/100g

    12-16

    Water, g/100g

    5.0-7.5

    2-Hydroxy-3-methyl-2-butenoic acid, %

    ≤8.0 (test method in Appendix B)

    alpha,beta-dihydroxyisovaleric acid, %

    ≤4.5 (test method in Appendix B)

    Other information

    1. Scope of use: beverages, milk and dairy products, cocoa products, chocolate and chocolate products, candies, baked food, sports nutrition products, and FSMPs.

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

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

    Pb, mg/kg

    ≤1.0

    As, mg/kg

    ≤1.0

    Chloroform, mg/kg

    ≤1.0

    Total colony count

    ≤1000

    Coliform bacteria

    ≤10

    New food additives (eight types)

    New food additives

    Butylated hydroxytoluene

    Functional classification: antioxidants

    Scope of use and usage level: The scope of use and usage level shall comply with the National Food Safety Standard for Food Additives-Butylated Hydroxytoluene (GB 2760).

    Specifications: The specifications apply to food additive butylated hydroxytoluene, which is made from a reaction of para-cresol and isobutene using catalysts such as concentrated sulfuric acid, sodium p-toluenesulfonate, and sodium benzenesulfonate, followed by distillation and recrystallization. The remaining content shall comply with the National Food Safety Standard for Food Additives – Butylated Hydroxytoluene (GB 1900).

    Note a: The mixture of para-cresol and ortho-cresol obtained by the reaction of phenol and methanol.

    New food enzymes

    No.

    Enzyme

    Source

    Donor

    1

    Phosphodiesterase I

    Leptographium

    procerum

    -

    2

    Lipase

    Komagataella

    phafi

    Streptomycessp.

    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 Spices

    Hydroxycitronellal

    Functional classification: food spices

    Application scope and usage level:

    Category number

    Food name

    Usage level

    Note

    -

    Prepared as food spice (except for the food categories listed in Table B1 of GB 2760)

    Use in appropriate amounts as required by production

    -

    Quality specifications:

    Applicable to food additive hydroxycitronellal produced from citronellol as a raw material through a chemical reaction. The remaining content shall comply with the provisions of the National Food Safety Standard for Food Additives – Hydroxycitronellal (GB 1886.117).

    New food nutrition enhancers

    2’-fucosyllactose, 2’-FL

    Functional classification: food nutrition enhancers

    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

    E. coli BL21 (DE3)

    Helicobacter spp.a

    E. coli W

    Helicobacter spp.a

    ais the donor of α-1, 2-fucosyltransferase

    Fructooligosaccharide

    Functional classification: food nutrition enhancers

    Application scope and usage level: The application scope and specification for fructooligosaccharide shall comply with the provisions in the National Food Safety Standard for Food Nutrition Enhancers (GB 14880).

    Specifications: This quality specification requirement applies to a mixture of sucrose trisaccharides to sucrose hexasaccharides obtained by purification, drying, and other processes using sucrose as raw material through the action of β-fructosyltransferase from Aspergillus japonicus. The rest of the content shall comply with the provisions of the National Food Safety Standard Food Nutrition Enhancers – Fructooligosaccharide (GB1903.40).

    New food additives with expanded scope/usage level

    No.

    Name

    Category number

    Food name

    Maximum level (g/kg)

    Note

    1

    Curdlan

    01.05.03

    Flavored fermented milk

    Use in appropriate amounts as required by production

    _

     

    16.05

    Microbial preparations for food processing (excluding 16.04)

    Use in appropriate amounts as required by production

    2

    Steviol glycosides (enzyme)

    Count as steviol equivalents

    New food-related products

    Food contact additives with expanded use scope/level

    Name

    CAS number

    Range of application

    Maximum level

    Polyisobutylene

    9003-27-4

    Adhesives (for direct/indirect food contact)

    35

    Butene, polymer with

    2-methyl-1-propene

    9044-17-1

    Adhesives (for direct/indirect food contact)

    35

    2-Propenoic acid polymer withethene, ammoniumsalt

    25212-83-3

    Paper and paperboard

    16.7 mg/dm2

    Ethanaminium, N,N,N-trimethyl-2-

    [(1-oxo-2-propen-1-yl)oxy]-, chloride (1:1), polymer with

    2-propenamide modified with propenoic acid

    69418-26-4

    Paper and paperboard

    0.6

    New food contact resin

    Name

    CAS number

    Range of application

    Maximum level

    2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid, 2-methyl-, 1,2-ethanediyl ester

    126969-53-7

    Plastic

    Use in appropriate amounts as required by production.

    New food contact resin with expanded scope/usage level

    Name

    CAS number

    Range of application

    Maximum level

    2,6-Naphthalenedicarboxylic acid, 2,6-dimethylester, polymer with 1,4-cyclohexanedimethanol, 1,2-ethanediol, 2,2’-oxybis[ethanol] and β33, β9 β9-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol

    2146168-28-5

    Plastic

    Use in appropriate amounts as required by production.

    New food contact materials

    Name

    CAS number

    Range of application

    Maximum level

    Chromium nitride made from nitrogen and chromium

    12053-27-9; 24094-93-7

    /

    Use in appropriate amounts as required by production.

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