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 |
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 | — |
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 | |
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:
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- China infant formula milk powder registration
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