[Updated] China Food Additives Updates in 2024: NHC Approved Eight New Food Additives

December 13, 2024 [Approved]

On December 13, 2024, China National Health Commission (NHC) approved eight new food additives. This approval list includes three enzyme preparations, one food spice, one nutritional fortification substance, two food additives with expanded usage scope and one nutritional fortification substance with expanded usage scope. Details are as follows:

Three enzyme preparations

Enzyme	Source	Donor
Glucoamylase	Aspergillus niger	Penicillium oxalicum
Serine protease	Fusarium venenatum	Fusarium oxysporum
Lipase	Komagataella phafi	Aspergillus oryzae

One food spice

Name	Food classification no.	Food name	Maximum usage (g/kg)	Notes
4-Hydroxy-2,5-dimethyl-3-(2H)-furanone	/	Formulated as a food flavoring for use in various foods (excluding those in food category Table B.1 of GB 2760-2014).	As necessary	/

One new food nutritional fortification substance

2'-FL

Nutritional fortification substance	Source	Donor
2’-fucosyllactose	Escherichia coli BL21(DE3)	Bacteroides fragilis ^a
2’-fucosyllactose	Escherichia coli BL21(DE3)	Escherichia spp. ^a

Note: ^a refers to α-1,2-fucosyltransferase donor.

Two food additives with expanded usage scope

Name	Food classification no.	Food name	Maximum usage (g/kg)	Notes
Sodium cyclamate, calcium cyclamate	01.02.02	Flavored fermented milk	0.65	As cyclohexylamino sulfonic acid equivalent
Sodium cyclamate, calcium cyclamate	16.07	Others (only for konjac gel products)	1.0	As cyclohexylamino sulfonic acid equivalent
Steviol glycosides	01.03.02	Milk powder and cream powder	0.3	As steviol equivalent
	01.06.04	Processed cheese and cheese products	0.4
	04.03.02.03	Pickled edible mushrooms and algae	0.23
	06.07	Convenience rice and noodle products	0.4

One nutritional fortification substance with expanded usage scope

Name	Food classification no.	Food name	Maximum usage (g/kg)	Notes
(6S)-5-Methyl tetrahydrofolate, amino glucose salt	13.05	Other foods for special dietary uses, excluding 13.01-13.04 (only for nutritional supplements for pregnant women and breastfeeding mothers)	As folic acid, follow the regulations for folic acid in the GB 31601.	/

October 24, 2024 [Proposed]

October 10, 2024 [Approved]

September 26, 2024 [Proposed]

On September 26, 2024, China National Center for Food Safety Risk Assessment (CFSA) opened eleven new food additives for public feedback. This includes three enzymes, two food spices, three nutritional fortification substances, two food additives with expanded usage scope, and one food nutritional fortification substance with expanded usage scope. Any comments can be submitted to [email protected] before October 26, 2024. Details are as follows:

Three enzyme preparations

Enzyme	Source	Donor
Glutamine transaminase	Bacillus licheniformis	Streptomyces mobaraensis
Phosphodiesterase I	Leptographium procerum	/
Lipase	Komagataella phaffi	Streptomyces sp.

Two food spices

Name	Food Classification Name	Maximum usage
trans-Anethole	Formulated as a food flavoring for use in various foods (excluding those in food category Table B.1 of GB 2760-2014).	As necessary
Hydroxycitronellal	Formulated as a food flavoring for use in various foods (excluding those in food category Table B.1 of GB 2760-2014).	As necessary

Three new food nutritional fortification substances

3'-FL

Name	Food classification no.	Food Classification Name	Maximum usage (g/kg)	Notes
3-fucosyllactose，3-FL	01.03.02	Modified milk powder (Only milk powder for children)	0.25-0.9 g/L (calculated as pure product in ready-to-eat form; for powdered products, adjust usage by reconstitution factor)	When used in combination with 2'-fucosyllactose, lacto-N-neotetraose, galacto-oligosaccharides, fructo-oligosaccharides, inulin, and raffinose, the total amount of these substances should not exceed 64.5 g/kg."
	13.01.01	Infant formula
	13.01.02	Infant formula for older infants and young children
	13.01.03	Infant formula for special medical purpose

β-Alanine

Name	Food classification no.	Food Classification Name	Usage amount	Notes
β-Alanine	13.05	Other foods for special dietary use excluding 13.01-13.04(limited to sports nutrition food)	2-4 g/day	/

Fructooligosaccharide

The usage scope and amount of this substance should comply with the approved regulations for fructo-oligosaccharides in the GB 14880.

Two food additives with expanded usage scope

Name	Food classification no.	Food Classification Name	Maximum usage (g/kg)	Notes
Sucralose	04.01.02.08	Candied fruits	2.8	/
Acesulfame potassium	14.08	Flavored beverages	0.5	For ready-to-drink beverages, the corresponding amount in solid beverages may be increased according to the dilution factor.

One food nutritional fortification substance with expanded usage scope

Name	Food classification no.	Food Classification Name	Maximum usage (g/kg)	Notes
2’-FL	13.02.01	Cereal-based complementary foods for infants and young children	0.7-2.4 g/L (calculated based on the pure product, in ready-to-eat state; for powdered products, the amount used is calculated based on the dilution factor)	When used in combination with lactulose-N-neohexose, oligofructose, oligogalactose, inulin, and xylo-oligosaccharides, the total amount of such substances should not exceed 64.5g/kg.
2’-FL	13.02.02	Canned complementary foods for infants and young children

August 14, 2024 [Proposed]

August 5, 2024 [Approved]

June 24, 2024 [Proposed]

On June 24, 2024, China National Center for Food Safety Risk Assessment (CFSA) opened nine new food additives for public feedback. This includes one food additive, three enzyme preparations, one food flavoring, two nutritional fortification substances, and two food additives with expanded usage scope. Any comments can be submitted to [email protected] before July 25, 2024. Details are as follows:

One new food additive

Food additive	Source	Donor
Steviol Glycosides from fermentation	Escherichia coli BL21(DE3)	Taxus canadensis ^a, Stevia rebaudiana ^b, Arabidopsis thaliana ^c, Oryza sativa ^d

Notes:

^a Donor of geranylgeranyl diphosphate synthase;

^b Donor of pyrophosphate synthase, isopimaradiene synthase, isopimaradiene oxidase, cytochrome P450 oxidoreductase, and glycosyltransferase;

^c Donor of cytochrome monooxygenase;

^d Donor of glycosyltransferase.

Three enzyme preparations

Enzyme	Source	Donor
Glucoamylase	Aspergillus niger	Penicillium oxalicum
Serine protease	Fusarium venenatum	Fusarium oxysporum
Lipase	Komagataella phafi	Aspergillus oryzae

One new food flavoring

Name	Function
4-Hydroxy-2,5-dimethyl-3-(2H)-furanone	Food flavoring

Two new food nutritional fortification substances

2'-FL

Nutritional fortification substance	Source	Donor
2'-fucosyllactose	Escherichia coli BL21(DE3)	Bacteroides fragilis ^a
2'-fucosyllactose	Escherichia coli BL21(DE3)	Escherichia spp. ^a

Note: ^a refers to α-1,2-fucosyltransferase donor.

LNT

Name	Food classification no.	Food name	Usage amount	Notes
Lacto-N-tetraose	01.03.02	Modified milk powder (only for the milk powder for children)	0.23-1.82 g/L (Based on pure product, calculated in ready-to-eat form, the usage amount for powdered products should be converted according to the dilution factor.)	When used in combination with 2'-FL, LNnT, GOS, FOS, Polyfructose, and raffinose, the total amount of these substances should not exceed 64.5g/kg.
	13.01.01	Infant formula
	13.01.02	Formula for older infants and young children
	13.01.03	Infant formula for special medical purpose

Two food additives with expanded usage scope

Name	Food classification no.	Food Classification Name	Maximum usage (g/kg)	Notes
Sodium cyclamate	01.02.02	Flavored fermented milk	0.65	Calculated as cyclohexylamine sulfonate
Sodium cyclamate	16.07	Other (only Konjac gel products)	1.0	Calculated as cyclohexylamine sulfonate
Steviol glycosides	01.03.02	Modified milk powder and cream powder	0.3	Calculated as steviol equivalents
	01.06.04	Processed cheese and cheese products	0.4
	04.03.02.03	Pickled edible fungi and algae	0.23
	06.07	Instant wheat or rice products	0.4

May 10, 2024 [Proposed]

March 13, 2024 [Approved]

On March 13, 2024, China National Health Commission (NHC) approved twelve new food additives. This approval list includes two novel food additives, three new enzyme preparations, and two nutritional fortification substances, one of which is 2'FL. Additionally, five food additives received approval for expanded scope and amount of use. Details are as follows:

Two new food additives

One antioxidant

Name

Function

Food classification no.

Food category

Maximum usage (g/kg)

Notes

Mixed tocotrienol tocopherol concentrate

Antioxidant

02.01.01

Vegetable oil and fat

0.2

Calculated as total tocopherols and total trienyl tocopherols.

One sweetener

Name	Food classification no.	Food Classification Name	Usage amount	Notes
Enzymatically produced steviol glycosides	01.01.03	Modified milk	0.18	Can be used alone or mixed with steviol glycosides, calculated as steviol equivalent.
	01.02.02	Flavored fermented milk	0.2
	03.01	Ice cream	0.5
	05.02.01	Gummy candies	3.5
	14.0	Beverages (except the categories in 14.01, 14.02.01 and 14.02.02)	0.2	Can be used alone or in combination with steviol glycosides, calculated on steviol alcohol equivalence; for ready-to-drink beverages, the corresponding amount in solid beverages may be increased according to the dilution factor.

Three new enzyme preparations

Enzyme	Source	Donor
D-psicose 3-epimerase	Bacillus subtilis	Clostridium scindens ATCC35704
Cyclomaltodextin glucanotransferase	Anoxybacillus caldiproteolyticus	/
Cellulase	Penicillium oxalicum	/

Two new nutritional fortification substances

2'-FL

Name	Source	Donor
2'-fucosyllactose	Escherichia coli BL21(DE3)	Helicobacterpylori^a

Note: ^arefers to α-1,2-fucosyltransferase donor. In addition, the usage ammount, application scope, and quality specifications for 2'-FL shall be implemented in accordance with the notification released on October 7, 2023.

d-ribose

Name	Food classification no.	Food Classification Name	Usage amount	Notes
d-ribose	13.05	Foods for special dietary use other than those in 13.01-13.04 (limited to sports nutrition foods).	1-2 g daily	/

Five food additives with expanded scope and amount of use

Name	Function	Food classification no.	Food Classification Name	Maximum usage (g/L)	Notes
Propylene glycol alginate	Thickener	06.05.02 .01	Vermicelli, glass Noodles	1.5	/
Propylene glycol alginate	Thickener	06.05.02 .04	Tapioca pearls	1.5	/
Polyoxyethylene (20) sorbitan monooleat	Emusifier	16.03	Collagen sausage casings	0.5
Ascorbyl palmitate (enzymatic)	Antioxidant	01.03.02	Modified milk powder and creamer powder	0.2	Calculated as ascorbic acid in fats
		07.01	Bread	0.2	/
		14.05.01	Tea (based) beverages	0.2	Calculated for the ready-to-drink state, the corresponding amount in solid beverages should be increased according to the dilution factor
Rosemary extract	Antioxidant	04.05.02	Processed nuts and seeds	0.3	/
Sucralose	Sweetener	04.05.02.01.01	Roasted nuts and seeds in shell	4.0	/
Sucralose	Sweetener	04.05.02.01.02	Roasted shelled nuts and seeds	2.0	/

March 13, 2024 [Proposed]

On March 13, 2024, China National Center for Food Safety Risk Assessment (CFSA) opened seven new food additives for public feedback. This includes two food additives, three nutritional fortification substances for use in infant formula, one food additive with expanded usage scope and one nutritional fortification substance with expanded usage scope. Any comments can be submitted to [email protected] before April 13, 2024. Details are as follows:

Two new food additives

One antioxidant

Name

Function

Food classification no.

Food category

Maximum usage (g/kg)

Notes

Hydroxytyrosol

Antioxidant

02.01.01

Vegetable fats and oils

0.05

/

One processing aid

Name	Function	Application scope
Methylene chloride	Extraction solvent	Tea decaffeination process (residual amount ≤ 2 mg/kg)

Three new nutritional fortification substances

2'-FL

Name

Source

Donor

2'-fucosyllactose, 2'-FL

Escherichia coli BL21 star

(DE3)

Escherichia coli O126^a

Note: ^a refers to α-1,2-fucosyltransferase donor. In addition, the usage ammount, application scope, and quality specifications for 2'-FL shall be implemented in accordance with the notification released on October 7, 2023.

3'-SL

Name	Food classification no.	Food Classification Name	Usage amount	Notes
3'-Sialyllactose sodium salt, 3'-SL	13.01.01	Infant formula	0.11~0.24 g/L (Based on 3'-sialyllactose, calculated as ready-to-eat, the amount used for powdered products may be increased according to the dilution factor.)	When mixed with 2'FL, LNnT, 6’SL, GOS, FOS, polyfructose and raffinose, the total amount of such substances shall not exceed 64.5g/kg.
	13.01.02	Follow-up infant and young children formula
	13.01.03	Infant formula for special medical purpose

6'-SL

Name	Food classification no.	Food Classification Name	Usage amount	Notes
6'-Sialyllactose sodium salt, 6'-SL	13.01.01	Infant formula	0.14~0.40 g/L (Based on 6'-sialyllactose, calculated as ready-to-eat, the amount used for powdered products may be increased according to the dilution factor.)	When mixed with 2'FL, LNnT, 3'SL, GOS, FOS, polyfructose and raffinose, the total amount of such substances shall not exceed 64.5g/kg.
	13.01.02	Follow-up infant and young children formula
	13.01.03	Infant formula for special medical purpose

One food additive with expanded usage scope

Name	Function	Food classification no.	Food category	Maximum usage (g/L)	Notes
Polyglycerol polyricinoleate (polyglycerol esters of interesterified ricinoleic acid) (PGPR)	Emulsifier	01.05.03	Modified light cream	10	/

One nutritional fortification substance with expanded usage scope

Name	Food classification no.	Food Classification Name	Usage amount	Notes
(6S)-5-methyltetrahydrofolic acid, glucosamine salt	13.05	Other foods for special dietary use except the items in 13.01-13.04 (only for nutrient supplementary food for pregnant and lactating women)	Comply with requirements of folic acid in GB 31601.	/

Nutrition fortification substance	Source	Donor
Lacto-N-neotetraose	Escherichia coli BL21（DE3）	Neisseria spp. ^a and Helicobacter spp. ^b

Name	Function	Scope of Use
Hydrogen peroxide	Desulfurizer	Processing technology for yeast-derived products

Food additive	Function
Butylated hydroxytoluene (BHT)	Antioxidant