On May 14, 2025, China National Center for Food Safety Risk Assessment (CFSA) issued 10 new food additives for public comments, including 1 new enzyme, 1 new food nutrition enhancers, 3 food additive with expanded scope, 2 food nutrition enhancer with expanded scope and 3 food additives with additional requirements for quality specifications. Comments are welcomed before October 26, 2024. 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)
| SN | Name | Category number | Food name | Maximum level （g/Kg） | Remark |
|
1 |
(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). | — |
| 2 | 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 H₂O₂ 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. | ||
(Source: CIRS Group)
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