China CFSA is Collecting Public Comments on 8 New Food Additives

On October 26, 2023, China National Center for Food Safety Risk Assessment (CFSA) issued 8 new food additives for public comments, including 1 new food additive, 2 new food enzymes, 1 new food nutrition enhancer and 4 food additives with expanded scope. The deadline for public comments is November 21, 2023. Details are as follows:

New food additive (1 type)

  • Name: Rebaudioside M;
  • Application scope and maximum usage level:
Category numberFood name/categoryMaximum level (g/kg)Remark
01.01.03Modified milk0.18Count as steviol
01.02.02Flavored fermented milk0.2
03.01Ice cream and ice milk0.5
05.02.01Gum-based candy3.5
14.0Beverages (excluding 14.01 packaged drinking water)0.2Count as steviol; count as the state of ready to drink, increase the usage of solid drinks according to the dilution ratio.

Quality specifications: It is applicable to the food additive Rebaudioside M, which is prepared through the efficient catalysis of sucrose synthase, β-1,3-galactosyltransferase, and β-1,2-glucosyltransferase, followed by alcohol dissolution, filtration crystallization, and drying using the the main component, Rebaudioside A, found in steviol glycosides as the raw material. The production strain of Rebaudioside M should undergo safety assessment and meet the requirements outlined in Appendix A.

Appendix A Information on the production strain of Rebaudioside M

Food additiveSourceDonor
Rebaudioside ME.coli BL21 (DE3)Methylocaldum szegediense a, Steviarebaudiana Bertoni b and Solanum tuberosum c

a is the donor of sucrose synthase

b is the donor of β-1,3-galactosyltransferase

c is the donor of β-1,2-glucosyltransferase

New food enzymes (2 types)

1Cyclomaltodextin glucanotransferaseAnoxybacilluscaldiproteolyticus
2CellulasePenicillium oxalicum

The quality specifications of food enzymes shall comply with the provisions specified in National Food Safety Standard – Food Additive – Food Enzyme (GB 1886.174).

New food nutrition enhancer (1 type)

  • Name: 2’-fucosyllactose, 2’-FL
  • Application scope, maximum usage level and quality specifications: It shall be consistent with the requirements specified in NHC Notice No. 8, 2023 (except Appendix C – Information on the production strain of 2’-fucosyllactose). Details of the the production strain are as follows.

Table 1 Information on the production strain of 2’-fucosyllactose

Nutrition enhancerSourceDonor
2’-fucosyllactoseEscherichia coliBL21(DE3)Helicobacter pylori a

a is the donor of α-1, 2-fucosyltransferase

Food additives with expanded scope (4 types)

No.NameFunctionCategory numberFood name/categoryMaximum level (g/kg)Remark
1Tomato redColorant08.02.01Seasoned meat products (adding seasonings to fresh meats)0.12Counted as tomato red
08.02.02Cured meat products (e.g., salt meats, cured meats, dried salted duck, Chinese ham and sausage)0.018
08.03.05Sausage0.35 meat crisps0.26
2Polyoxyethylene (20) sorbitan monooleatEmulsifier16.03Collagen casing0.5
3Rosemary extractAntioxidant04.05.02Processed nuts and seeds0.3
4Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate)Antioxidant16.07Others (lutein esters only)50
(Source: CIRS GROUP)

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