China CFSA Collects Public Comment on Nine New Food Additives

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On June 24, 2024, the China National Center for Food Safety Risk Assessment (CFSA) issued nine new food additives for public comment: one new food additive, three new food enzymes, one new food flavoring, two new food nutrition enhancers, and two food additives with expanded scope. Comments are welcomed before July 25, 2024. Details are as follows:

New food additive (one type)

1) Steviol glycosides from fermentation

The scope of use and use level of steviol glycosides from fermentation shall comply with the provisions of GB2760-2024 National Food Safety Standard for the Use of Food Additives. It can be used alone or in combination with steviol glycosides and enzymatically produced steviol glycosides, calculated as steviol equivalents.

The specifications apply to steviol glycosides from fermentation, a food additive produced from glucose through fermentation with recombinant Escherichia coli BL21 (DE3), followed by inactivation, resin treatment, concentration, crystallization, drying, and other processes. Its production strain shall undergo safety assessments and comply with the requirements outlined in Appendix A.

Appendix A – Information on the production strain for producing steviol glycosides from fermentation

Food additive

Source

Donor

Steviol Glycosides

from fermentation

Escherichia coli

BL21(DE3)

Taxus canadensis^a, Stevia rebaudiana^b , Arabidopsis

Thaliana^c, and Oryza sativa^d

^ais the donor for geranylgeranyl pyrophosphate synthase

^bis the donor for pyrophosphoric acid synthase, kaurenoic acid synthase, kaurenoic acid oxidase, and cytochrome P450 oxidoreductase and glycosyltransferase

^cis the donor for cytochrome monooxygenase

^dis the donor for glycosyltransferase

New food enzymes (three types)

No.	Enzyme	Source	Donor
1	Glucoamylase	Aspergillus niger	Penicillium oxalicum
2	Serine protease	Fusarium venenatum	Fusarium oxysporum
3	Lipase	Komagataella phaffi	Aspergillus oryzae

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

New food flavoring (one type)

1) 4-Hydroxy-2,5-dimethyl-3-(2H)-furanone

The specifications apply to 4-Hydroxy-2,5-dimethyl-3-(2H)-furanone, a food additive produced from rhamnose.

Other aspects shall comply with the provisions of GB28365 National Food Safety Standard – Food Additive - 4-Hydroxy-2,5-dimethyl-3-(2H)-furanone.

New food nutrition enhancers (two types)

1) 2’-fucosyllactose, 2’-FL

The scope of use, use levels, and specifications for 2’-FL shall comply with Notice No. 8 of 2023 by the National Health Commission (NHC) (excluding Appendix C – Information on the production strain for producing 2’-fucosyllactose). Details of the production strain are as follows:

Table 1 Information on the production strain for producing 2’-fucosyllactose

Nutrition enhancer

Source

Donor

2’-fucosyllactose

Escherichia coli

BL21(DE3)

Bacteroides fragilis^a

Escherichia coli

BL21(DE3)

Escherichia spp.^a

^ais the donor for α-1,2-fucosyltransferase

2) Lacto-N-tetraose, LNT

Use levels and scope of use:

Category number	Food name/category	Maximum level (g/kg)	Remark
01.03.02	Modified milk (for infants only)	0.23-1.82 g/L (count on a pure basis and ready-to-eat state, for powdery products, the use level should be increased by times of brewing)	When mixed with 2’-fucosyllactose (2’-FL), lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructooligosaccharides (FOS), polyfructose, and raffinose, the total amount shall not exceed 64.5 g/kg.
13.01.01	Infant formula
13.01.02	Older infants and young children’s food
13.01.03	Infant formula for special medical purposes

The specifications apply to Lacto-N-tetraose, a nutritional enhancer produced from lactose through fermentation, purification, drying, and other processes. Its production strain shall undergo safety assessments and comply with the requirements outlined in Appendix C.

Appendix C – Information on the production strain for producing Lacto-N-tetraose

Nutrition enhancer

Source

Donor

Lacto-N-tetraose

Escherichia coli

BL21 star (DE3)

Neisseria spp^a, Salmonella spp.^b

^ais the donor for β-1,3-N-acetylglucosamine aminotransferase

^bis the donor for β-1,3-galactosyltransferase

Food additives with expanded scope (two types)

No.	Name	Category number	Food name/category	Maximum level (g/kg)	Remarks
1	Sodium cyclamate	01.02.02	Flavored fermented milk	0.65	Count as cyclamic acid
1	Sodium cyclamate	16.07	Others (konjac gel products only)	1.0	Count as cyclamic acid
2	Steviol glycosides	01.03.02	Formulated milk powder and formulated cream powder	0.3	Count as steviol equivalents
		01.06.04	Cheese and processed cheese	0.4
		04.03.02.03	Pickled edible fungi and seaweeds	0.23
		06.07	Instant rice flour products	0.4

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