NHC Newly Approved 1 New Food Raw Materials, 8 New Food Additives, and 2 Food-related Products

On December 13, 2024, National Health Commission of the People’s Republic of China (NHC) issued an announcement (No. 5 of 2023) for “Three New Foods” with 11 products approved, including 1 new food raw materials, 8 new food additives, and 2 food-related products.

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Details are as follows:

New food raw materials (1 type)

Camellia petelotii culture

Name	Camellia petelotii culture
Basic information	Source: Camellia petelotii (Merrill) Sealy, former name: Camellia chrysantha (Hu)Tuyama
Brief introduction of production process	Made from the leaves of Camellia petelotii (Merrill) Sealya through processes such as sterilization, callus induction, cultivation, collection, drying, and grinding.
Recommended intake	≤1.5 g/day
Quality requirements	Properties	Brown or brownish-yellow powder or granules
	Total flavonoids, %	≥4.0
	Tea polyphenols, %	≥6.0
	Moisture, %	≤10.0
	Ash, %	≤10.0
Other information	1. The labels and instructions shall bear a statement that they should not be consumed by infants, pregnant women and lactating women. 2. Food safety indicators must meet the following requirements:
	Pb, mg/kg	≤1.0
	Hg, mg/kg	≤0.1
	As, mg/kg	≤0.3
	Total colony, CFU/g	≤30000
	Coliform bacteria, MPN/g	≤0.92
	Molds and yeasts, CFU/g	≤50
	Salmonella, /25g	Not Detected
	Staphylococcus aureus, /25g	Not Detected
	Plant Growth Regulators, mg/kg	≤0.05

New food additives (8 types)

New food enzymes (3 types)

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

New Food Spices (1 type)

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

Application scope: food spices

Maximum usage level:

Category number	Food name	Usage level	Note
-	Prepared as food spice (except for the food categories listed in Table B1 of GB 2760)	Use in appropriate amounts as required by production	-

Quality specifications:

Applicable to 4-Hydroxy-2,5-dimethyl-3-(2H)-furanone, prepared from rhamnose as the raw material. It shall follow the National Food Safety Standard - Food Additives 4-Hydroxy-2,5-Dimethyl-3(2H)-Furanone" (GB 28365).

New food nutrition enhancers (1 type)

Name: 2’-fucosyllactose， 2’-FL

Application scope, maximum usage level and quality specifications: The usage, application scope, and quality specification requirements for 2'-Fucosyllactose shall follow the Notice No. 8 of 2023 issued by the National Health Commission (except for the information on the production strains used for 2'-Fucosyllactose production in Appendix C). The information on the production strains for this new nutrition enhancer is provided in the table below.

Nutrition enhancer	Source	Donor
2’-fucosyllactose	E. coli BL21 (DE3)	Bacteroides fragilis^a
2’-fucosyllactose	E. coli BL21 (DE3)	Escherichia spp.^a

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

New food additives with expanded scope (2 types)

No.	Name	Category number	Food name	Maximum level (g/kg)	Note
1	Sodium N-cyclohexylsulfamate	01.02.02	Flavored fermented milk	0.65	Count as Sodium N-cyclohexylsulfamate
1	Sodium N-cyclohexylsulfamate	16.07	Others (only konjac gel products)	1.0	Count as Sodium N-cyclohexylsulfamate
2	Stevioside	01.03.02	Milk powder and cream powder (formulated)	0.3	Count as Stevioside
		01.06.04	Reprocessed cheese and cheese products	0.4
		04.03.02.03	Pickled edible mushrooms and algae	0.23
		06.07	Convenience rice and noodle products	0.4

Food nutrition enhancers with expanded scope (1 type)

Name	CAS number	Range of application	Use level
(6S)-5-Methyl tetrahydrofolate, Glucosamine salt	13.05	Other special dietary foods excluding 13.01 to 13.04 (for nutritional supplements for pregnant and lactating women only)	Based on folic acid content, the regulations for folic acid in the 'National Food Safety Standard for Nutritional Supplements for Pregnant and Lactating Women' (GB 31601) shall apply.

New food-related products (2 types)

Food contact additives with expanded scope (1 type)

Name	CAS number	Range of application	Maximum level
1,3,5-Trimethyl-2,4,6-tri(3,5-di-tert-butyl-4-hydroxybenzyl)benzene	1709-70-2	Plastic: Carbon monoxide-ethylene-propylene ternary polymer	0.5

New food contact resin (1 type)

Name	CAS number	Range of application	Maximum level
Poly(3-hydroxybutyrate-3-hydroxyhexanoate)	147398-31-0	Plastic	Use in appropriate amounts as required by production.

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