China CFSA Collects Public Comments on Ten New Food Additives

China,Food,Additive,Public,Consultation

On July 15, 2025, China National Center for Food Safety Risk Assessment (CFSA) issued ten new food additives for public comments, including two new enzymes, two new food nutrition enhancers, one food additive with expanded scope, one processing aids with expanded scope, one food nutrition enhancer with expanded scope and three food additives with additional requirements for quality specifications. Comments are welcomed before August 14, 2025. Details are as follows:

New enzyme preparations for the food industry (two types)

Enzyme	Source	Donor
D-psicose 3-epimerase	Escherichia coli K-12 MG1655	Ruminococcus sp.5_1_39B_FAA
D-psicose 3-epimerase	Bacillus subtilis	Agrobacterium tumefaciens C58
Deaminase	Streptomyces murinus	—

The quality specification requirements of enzyme preparations for the 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 (two types)

3-fucosyllactose, 3-FL

Functional classification: food nutrition enhancers

Applicable scope and maximum levels:

The usage level, application scope, and quality specifications of 3-fucosyllactose shall be implemented in accordance with the draft consultation document titled "Call for Public Comments on Eight New Varieties of Food Additives Including Aminopeptidase", issued by the China National Center for Food Safety Risk Assessment, specifically the section pertaining to the nutritional enhancer lacto-N-tetraose. Appendix C, which contains information on the production strain used for manufacturing lacto-N-tetraose, is excluded from this reference. The production strain information for this new nutritional enhancer is provided in the table below.

Name	Source	Donor
3-FL	Escherichia coli BL21 (DE3)	Azospirillum lipoferum B510

Lacto-N-tetraose, LNT

The usage level, application scope, and quality specifications of lacto-N-tetraose shall be implemented in accordance with the draft consultation document titled "Call for Public Comments on Eight New Varieties of Food Additives Including Aminopeptidase", issued by the China National Center for Food Safety Risk Assessment, specifically the section pertaining to the nutritional enhancer lacto-N-tetraose. Appendix C, which contains information on the production strain used for manufacturing lacto-N-tetraose, is excluded from this reference. The production strain information for this new nutritional enhancer is provided in the table below.

Name	Source	Donor
Lacto-N-tetraose	Escherichia coli BL21 (DE3)	Neisseria spp. and Escherichia coli

Food additives with expanded scope (one type)

Name	Function	Category No.	Food name	Maximum level (g/Kg)	Remark
Gellan gum	Thickener	01.05.01	Light cream	Use according to processing requirements	—

Processing aids with expanded scope (one type)

Name	Function	Scope of use
Bentonite	Clarifying agent	Production process of starch sugars — applicable to resistant dextrin only

Food nutrition enhancer with expanded scope (one type)

Name	Category number	Food name	Maximum level	Remark
Casein phosphopeptide	01.03.02	Modified milk powder	≤12.8 g/kg	—
Casein phosphopeptide	13.05	Sports nutrition food	≤1.6 g/kg	For solid beverages, usage amount increases proportionally with the reconstitution ratio.

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

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

Escherichia coli BL21 (DE3)

Escherichia coli

Kluyveromyces lactis

DSM70799

Bacillus spp.

Nutritional enhancer lacto-N-tetraose

The quality specifications of this substance shall be implemented in accordance with Announcement No. 8 of 2023 issued by the National Health Commission of China, excluding Appendix D, which contains information on the production strain used for manufacturing lacto-N-neotetraose. The production strain information for this new nutritional fortifier is provided in the table below.

Name	Source	Donor
Lacto-N-tetraose	Escherichia coli K-12 MG1655	Neisseria spp. and Helicobacter spp.

Enzymatically produced steviol glycosides

These quality specifications apply to the food additive steviol glycosides (enzymatic conversion), which are derived from Rebaudioside A extracted from the leaves of Stevia rebaudiana Bertoni and subsequently produced through a high-efficiency cascade reaction catalyzed by UDP-glucosyltransferase and sucrose synthase, followed by refinement and purification. The resulting glycosides include Rebaudioside M2 (as the main component), along with minor amounts of Rebaudioside D2, Rebaudioside D, Rebaudioside M8, Rebaudioside A, and Rebaudioside B. The production strains used for enzymatic conversion of steviol glycosides shall undergo safety evaluation and comply with the requirements set out in Appendix C.

Table. Physicochemical Specifications

Item	Specification	Test Method
Rebaudioside M2, w/% ≥	75.0	See Appendix A
Steviol glycosides, w/% ≥	95.0	See Appendix A
Ash, w/% ≤	1.0	GB 5009.4
Loss on drying, w/% ≤	6.0	GB1886.355-2022
pH	4.5-7.0	GB1886.355-2022
Lead (Pb), mg/kg ≤	1.0	GB 5009.75 or GB 5009.12
Arsenic (As), mg/kg ≤	1.0	GB 5009.76 or GB 5009.11
Methanol, mg/kg ≤	200	GB1886.355-2022
Ethanol, mg/kg ≤	5000	GB1886.355-2022

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).

Our food services in China include, but are not limited to:

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

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