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 |
|
1 |
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 |
Bacillussubtilisa, Escherichia colib, Helicobacter pyloric |
|
E. coli BL21 (DE3) |
Helicobacter pyloric, E.coli O126c |
|
|
E. coli K-12 MG1655 |
Helicobacter pyloric |
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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