China CFSA Collects Public Comments on Eight New Food Additives including Aminopeptidase, 3-FL, and LNT

On March 21, 2025, China National Center for Food Safety Risk Assessment (CFSA) issued eight new food additives for public comment: two new food additives, two new food nutrition enhancers, one food additive with expanded scope, two food processing aids with expanded scope and one food additive with supplemented quality specifications. Comments are welcomed before April 20, 2025.

Details are as follows:

1. New enzyme preparations for the food industry (two types)

S.N.	Enzyme	Source	Donor
1	Aminopeptidase	Trichoderma reesei	Aspergillus clavatus
2	Xylanase	Leptographium procerum	Fusarium verticillioides

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

2. New food nutrition enhancers (two types)

1) 3-fucosyllactose, 3-FL

Functional classification: food nutrition enhancers

Applicable scope and maximum levels:

Category number	Food name	Maximum level	Remarks
01.03.02	Infant formula	0.25-1.75 g/L (count as 3’-SL and the ready-to-eat state, for powdery products, the level of use should be increased by times of brewing)	When being mixed with (2’-FL, LNnT, GOS, FOS, polyfructose, and raffinose, the total amount must not exceed 64.5 g/kg.
13.01.01	Food for older infants and young children
13.01.02	Infant formula for special medical purposes
13.01.03	Infant formula

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 a safety assessment and comply with the requirements specified in Appendix C.

2) Lacto-N-tetraose, LNT

Functional classification: food nutrition enhancers

Category number	Food name/category	Usage level	Note
01.03.02	Modified milk powder (limited to milk powder for children)	0.25-1.82 g/L (Count as the state of ready to eat, for powdery products, the level of use should be increased by times of brewing)	When mixed with (2’-FL, LNnT, GOS, FOS, polyfructose, and raffinose, the total amount shall not exceed 64.5 g/kg.
13.01.01	Infant formula foods
13.01.02	Food for older infants and young children
13.01.03	Infant formula foods for special medical purposes

Quality specifications: Applicable to the new nutrition enhancer Lacto-N-neotetraose (LNnT), which is prepared through fermentation, purification, drying, and other processes using lactose as a raw material. The production strain of LNnT should undergo a safety assessment and comply with the requirements outlined in Appendix C.

3. Food additive with expanded scope (one type)

S.N.

Name

Category number

Food name

Maximum level （g/Kg）

Remark

Ascorbyl palmitate(enzyme)

13.01

Infant and young child formula

0.05

Ascorbic acid in fat/oil basis

13.02

Infant and young child complementary food

0.05

Ascorbic acid in fat/oil basis

4. Food processing aids with expanded scope (two types)

S.N.	Name	Functions	Application scope
1	sulfuric acid	Wall-breaking	Algae cell wall-breaking process
2	ethyl acetate	Extraction solvent	Algae-derived oil processing technology (residual amount ≤20 mg/kg)

5. Food additive with supplemented quality specifications (one type)

food nutrition enhancers 2’-fucosyllactose

The quality specifications for this substance shall comply with the requirements of the National Health Commission Announcement No. 8 of 2023 (except for the information on the production strains of 2'-fucosyllactose as outlined in Appendix C). The information regarding the production strains of this new nutritional supplement variety is provided in the table below.

Nutrition enhancer	Source	Donor
2’-fucosyllactose	Bacillus subtilis 168	Bacillussubtilis^a, Escherichia coli^b, Helicobacter pylori^c
	E. coli BL21 (DE3)	Helicobacter pylori^c, E.coli O126^c
	E. coli K-12 MG1655	Helicobacter pylori^c

^a is the donor for mannose-6-phosphate isomerase.

^b is the donor for phosphomannomutase, mannose-1-phosphate guanylyltransferase, GDP-mannose dehydratase, GDP-fucose synthase, lactose permease, and sugar efflux transporter proteins.

^c is the donor for α-1,2-fucosyltransferase.

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