China CFSA Collects Public Comments on Ten New Food Additives

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On May 14, 2025, China National Center for Food Safety Risk Assessment (CFSA) issued ten new food additives for public comments, including one new enzyme, one new food nutrition enhancer, three food additives with expanded scope, two food nutrition enhancers with expanded scope and three food additives with additional requirements for quality specifications. Comments are welcome before June 13, 2025. Details are as follows:

New enzyme preparations for the food industry (1 type)

Enzyme	Source	Donor
Branching enzyme	Bacillus subtilis	Rhodothermus obamensis

The quality specification requirements of enzyme preparations for food industry should be in accordance with the provisions of National Standard for Food Safety Food Additives Enzyme Preparations for Food Industry (GB 1886.174).

New food nutrition enhancers (1 type)

3-fucosyllactose, 3-FL

Functional classification: food nutrition enhancers

Applicable scope and maximum levels:

The quality specifications apply to the food nutrition enhancer 3-fucosyllactose prepared through fermentation, purification, drying, and other processes using lactose and glucose as raw materials. The production strain of 3’-FL shall undergo safety assessment and comply with the requirements specified in Appendix C.

Name

Source

Donor

3-FL

Escherichia coli K-12

MG1655

Bacteroides

gallinaceum

Food additives with expanded scope (3 types)

SN	Name	Category number	Food name	Maximum level （g/Kg）	Remark
1	Advantame	06.07	Instant cereal and noodle products (seasoned noodle products only)	0.03	—
2	Calcium alginate	01.06.04	Processed cheese and cheese products	5.0	—
		05.01.02	Chocolate and chocolate products, and Cocoa products except those classified under 05.01.01	5.0
		16.06	Puffed food	3.0
3	Xanthan gum	14.03.01	Dairy-containing beverages	1.0	For ready-to-drink products, the usage amount of corresponding powdered beverages should be increased according to the dilution ratio.

Food nutrition enhancer with expanded scope (2 types)

Name

Category number

Food name

Maximum level （g/Kg）

Remark

(6S)-5-Methyltetrahydrofolate, glucosamine salt

13.05

Special dietary foods other than categories 13.01 to 13.04 (limited to sports nutrition foods)

Folic acid content, calculated according to the Provisions on Folic Acid in the National Food Safety Standard—General Rules for Sports Nutrition Foods (GB 24154).

—

Calcium (6S)-5-methyl-THF

06.03.01

Wheat flour

Folic acid content, calculated according to the Provisions on Folic Acid for Wheat Flour in the National Food Safety Standard — Standard for Use of Nutritional Fortifiers in Food (GB 14880).

—

Food additives with additional requirements for quality specifications (3 types)

Enzymatically produced steviol glycosides

This quality specification applies to steviol glycosides (enzymatic conversion method) produced from the leaves of Stevia rebaudiana Bertoni. The production process includes extraction, purification, enzymatic conversion, flocculation filtration, resin treatment, concentration, and drying. The resulting food additive is rich in Rebaudioside AM. The production microorganisms used in the enzymatic conversion must undergo safety evaluation and comply with the requirements outlined in Appendix C.

Name

Source

Donor

Enzymatically produced steviol glycosides

Escherichia coli K-12

Arabidopsis thaliana, Stevia rebaudiana

Bertoni, Solanum

lycopersicum

Nutrition enhancer — 2’-Fucosyllactose

The quality specification requirements for this substance shall be implemented in accordance with the National Health Commission Announcement No. 8 of 2023 (excluding the production microorganism information for 2’-fucosyllactose in Appendix C). The production microorganism information for this new nutritional fortifier is listed in the table below.

Name

Source

Donor

2’-fucosyllactose

Corynebacterium

glutamicum ATCC13032

Corynebacterium

spp.

Calcium carbonate（Calcified Lithothamnion tophiforme source）

Functional classification: food nutrition enhancers

Specification: This quality specification applies to calcium carbonate produced from Lithothamnion tophiforme. The raw material is harvested from the seabed, then cleaned and screened. It undergoes sterilization by heating with water containing H?O? at 75°C for 1 hour, followed by drying, magnetic separation, grinding, and sieving to obtain the final food additive.

Table. Physicochemical Specifications

Item	Specification	Test Method
Calcium, w/% ≥	32	GB 5009.92
Magnesium, w/% ≥	2.2	GB 5009.241
Moisture, w/% ≤	5	GB 5009.3
Ash, w/% ≥	90	GB 5009.4
pH (1% aqueous solution)	9 -11	GB 5009.237
Pb, mg/kg ≤	1.0	GB 5009.75
As, mg/kg ≤	1.0	GB 5009.76
Cd, mg/kg ≤	0.5	GB 5009.15
Hg, mg/kg ≤	0.1	GB 5009.17
Note: Commercially available Calcium carbonate (Calcified Lithothamnion tophiforme source) products should use calcium carbonate that complies with this standard as the raw material. Corn starch and gum arabic that meet applicable standards may be added.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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