China CFSA is Collecting Public Comments on 8 New Food Additives including Rebaudioside M and 2’-FL

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 number	Food name/category	Maximum level (g/kg)	Remark
01.01.03	Modified milk	0.18	Count as steviol
01.02.02	Flavored fermented milk	0.2
03.01	Ice cream and ice milk	0.5
05.02.01	Gum-based candy	3.5
14.0	Beverages (excluding 14.01 packaged drinking water)	0.2	Count 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 additive	Source	Donor
Rebaudioside M	E.coli BL21 (DE3)	Methylocaldum szegediense a, Stevia rebaudiana 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)

No.	Enzyme	Source	Donor
1	Cyclomaltodextin glucanotransferase	Anoxybacillus caldiproteolyticus	—
2	Cellulase	Penicillium 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 enhancer	Source	Donor
2’-fucosyllactose	Escherichia coli BL21(DE3)	Helicobacter pylori a

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

Food additives with expanded scope (4 types)

No.	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Remark
1	Tomato red	Colorant	08.02.01	Seasoned meat products (adding seasonings to fresh meats)	0.12	Counted as tomato red
			08.02.02	Cured meat products (e.g., salt meats, cured meats, dried salted duck, Chinese ham and sausage)	0.018
			08.03.05	Sausage	0.35
			08.03.07.03	Dried meat crisps	0.26
2	Polyoxyethylene (20) sorbitan monooleat	Emulsifier	16.03	Collagen casing	0.5	—
3	Rosemary extract	Antioxidant	04.05.02	Processed nuts and seeds	0.3	—
4	Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate)	Antioxidant	16.07	Others (lutein esters only)	50

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