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China,Food,Additive,Material,Registration,Approval

On March 13, 2024, the National Health Commission of the People’s Republic of China (NHC) issued an announcement (No. 2 of 2024) on the approval of 23 “Three New Foods”, including 6 new food raw materials, 12 new food additives, and 5 new food-related products. Details are as follows:

New food raw materials (6 types)

Dendrobium protocorm

Name	Dendrobium protocorm
Basic information	Source: Dendrobium officinale Kimura et Migo or Dendrobium huoshanense C. Z. Tang et S. J. Cheng
Brief introduction of the production process	Protocorms are obtained through tissue culture using the seeds or stem of Dendrobium officinale Kimura et Migo or Dendrobium huoshanense C. Z. Tang et S. J. Cheng as raw materials, followed by collection, drying and other processes.
Recommended intake	Dehydrated products ≤ 3.5g/day
Other information	1. The labels and instructions shall bear a statement indicating that they should not be consumed by infants, pregnant women and lactating women, along with the recommended intake. 2. Food safety indicators must meet the following requirements:
	Pb, mg/kg ≤	1.0
	Hg, mg/kg ≤	0.1
	As, mg/kg ≤	0.3
	Colony count, CFU/g ≤	30000
	Coliforms, MPN/g ≤	0.92
	Mould and Yeast, CFU/g ≤	50
	Salmonella, /25g	0
	Staphylococcus aureus, /25g	0
	Plant growth regulator, mg/kg≤	0.05

Meso-zeaxanthin

Name	Meso-zeaxanthin
Basic information	Source: Tagetes erecta L. Structure: CAS number: 31272-50-1 Molecular Formula: C₄₀H₅₆O₂ Relative molecular mass: 568.88
Brief introduction of the production process	Prepared through dehydration, grinding, extraction, isomerization, purification, and other processes using flowers of natural Tagetes erecta L. as the raw material.
Recommended intake	≤ 8 mg/day (count as Meso-zeaxanthin)
Quality requirements	Property	Reddish orange powder
	Meso-zeaxanthin, g/100g ≥	54.0 (See Appendix A for the test methods)
	Moisture, g/100 g ≤	5.0
Other information	1. The applicable scope of use does not include infants and young children food. 2. The detection method for n-Hexane residue shall follow GB 24405. 3. Food safety indicators must comply with the following requirements:
	n-Hexane, mg/kg ≤		10.0
	Pb, mg/kg ≤		1.0
	Cd, mg/kg ≤		0.5
	Hg, mg/kg ≤		0.1
	As, mg/kg ≤		1.0
	benzo[a]pyrene, μg/kg ≤		2.0
	Colony count, CFU/g ≤		1000
	Coliforms, CFU/g ≤		10
	Mould, CFU/g ≤		100
	Yeast, CFU/g ≤		100
	Salmonella, /25g		0
	Staphylococcus aureus, /25g		0
	Listeria monocytogenes, /25g		0

Pichia kluyveri

Name

Pichia kluyveri

Other information

1. Being included in the List of Strains that Can be Used in Food, and approved for use in fermentation processing of fermented wine, fruit and vegetable juices and drinks, tea drinks and botanical drinks, excluding infants and young children food. The scope of use shall be indicated on the labels and instructions.

2. Food safety indicators shall comply with the provisions of GB 31639-2023 National Food Safety Standard - Food Processing Strains Preparation.

Bacillus subtilis DE111

Name

Bacillus subtilis DE111

Other information

1. Being included in the List of Strains that Can be Used in Food. The applicable scope of use does not include infants and young children food.

2. Food safety indicators shall comply with the provisions of GB 31639-2023 National Food Safety Standard - Food Processing Strains Preparation.

L-alpha-Glycerylphosphorylcholine

Name	L-alpha-Glycerylphosphorylcholine
Basic information	Structure: CAS number: 28319-77-9 Molecular formula: C₈H₂₀NO₆P Relative molecular mass: 257.22
Brief introduction of the production process	Prepared through condensation and esterification reactions, followed by decolorization, impurity removal, concentration, refinement, drying and other processes using polyphosphoric acid, choline chloride, R-3-Chloro-1,2-propanediol, sodium hydroxide and water as raw materials.
Recommended intake	≤ 600 mg/day (on a dry basis)
Other information	1. The labels and instructions shall bear a statement indicating that they should not be consumed by infants, pregnant women and lactating women, along with the unsuitable group and recommended intake. 2. See the Appendix for quality specifications and food safety indicators.

Leuconostoc pseudomesenteroides

Name

Leuconostoc pseudomesenteroides

Other information

1. Being included in the List of Strains that Can be Used in Food, and approved for use in fermented milk, flavored fermented milk, cheese, fermented milk drinks, lactobacillus drinks (non-solid beverages), cream, butter and anhydrous milkfat, excluding infants and young children food.

2. Food safety indicators shall comply with the provisions of GB 31639-2023 National Food Safety Standard - Food Processing Strains Preparation.

New food additives (12 types)

New food additives (2 types)

S.N.	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Remark
1	Mixed tocotrienol tocopherol concentrate	Antioxidant	02.01.01	Plant oils and fats	0.2	Counted as the total amount of tocopherol and tocotrienol
2	Enzymatically produced steviol glycosides	Sweetener	01.01.03	Modified milk	0.18	It can be used alone or in combination with steviol glycosides, and count as steviol equivalents.
			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; 14.02.01 fruit and vegetable juices (pulp); 14.02.02 concentrated fruit and vegetable juice (pulp)	0.2	It can be used alone or in combination with steviol glycosides, and count as steviol equivalents. Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.

Table A.1 Information on the production strain used for enzymatically produced steviol glycosides

Food additive

Source

Donor

Enzymatically

produced steviol

glycosides

Escherichia coli

BL21 (DE3)

Methylocaldum Szegediense ^a , Stevia rebaudiana Bertoni ^band Solanum tuberosum ^c

a refers to the donor of sucrose synthase

b refers to the donor of β-1,3-glycosyltransferase

c refers to the donor of β-1,2-glycosyltransferase

New food enzymes (3 types)

S.N.	Enzyme	Source	Donor
1	D-psicose 3-epimerase	Bacillus subtilis	Clostridium scindens ATCC35704
2	Cyclomaltodextin glucanotransferase	Anoxybacillus caldiproteolyticus	—
3	Cellulase	Penicillium oxalicum	—

*The quality specifications of the enzymes shall meet the provisions specified in GB 1886.174 National Food Safety Standard - Food Additives, Enzymes.

New food nutrition enhancers (2 types)

2’-fucosyllactose，2’-FL

The maximum levels, the scope of use and quality specifications shall meet the requirements outlined in NHC Notice No. 8 of 2023, excluding Appendix C. The production strain information is given in the Table below:

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

Nutrition enhancer	Source	Donor
2’-fucosyllactose	Escherichia coli BL21(DE3)	Helicobacter pylori ^a

^a refers to the donor of α-1, 2-fucosyltransferase

d-Ribose

Nutrition enhancer	Category number	Food name/category	Maximum level	Remark
d-Ribose	13.05	Foods for special dietary purposes excluding 13.01-13.04 (sports nutrition foods only)	1-2g/day	—

Food additives with expanded scope and usage levels (5 types)

S.N.	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Remark
1	Propyleneglycol alginate	Thickener	06.05.02.01	Bean vermicelli, bean noodles	1.5	—
1	Propyleneglycol alginate	Thickener	06.05.02.04	Round rice ball	1.5	—
2	Polyoxyethylene (20) sorbitan monooleat	Emulsifier	16.03	Collagen casing	0.5	—
3	Ascorbyl palmitate (enzymatic)	Antioxidant	01.03.02	Formulated milk powder and formulated cream powder	0.2	Count as the ascorbic acid in fat
			07.01	Bread	0.2	—
			14.05.01	Tea drinks	0.2	Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.
4	Rosemary extract	Antioxidant	04.05.02	Processes nuts and seeds	0.3	—
5	Sucralose	Sweetener	04.05.02.01.01	Shelled and cooked processed nuts and seeds	4.0	—
5	Sucralose	Sweetener	04.05.02.01.02	Unshelled and cooked processed nuts and seeds	2.0	—

New food-related products (5 types)

New food contact additives (2 types)

S.N.

Name

CAS number

Scope of use

Maximum level (%）

Chromium iron oxide

12737-27-8

Plastic

Bicyclo[2.2.1]

heptane-2,3-dicarboxylic acid, calcium salt (1:1), (1R,2R,3S,4S)-rel-

839683-04-4

Plastic: PP; PE

0.25

New food contact resins (2 types)

S.N.

Name

CAS number

Scope of use

Common category name

Maximum level (%)

Polybutylene succinate adipate

67423-06-7

Plastic

PBSA

Appropriate level

1,3-Benzenedicarboxylic acid, polymer with

1,4-benzenedicarboxylic acid and

1,4-cyclohexanedimethanol

26124-27-6

Plastic

PCT

Appropriate level

Food contact resins with expanded scope of use (1 type)

S.N.	Name	CAS number	Scope of use	Common category name	Maximum level (%)
1	Undecanoicacid,11-amino-,homopolymer	25587-80-8	Plastic	PA	Appropriate level

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China NHC Approves 6 New Food Raw Materials, 12 New Food Additives, and 5 New Food-Related Products

New food raw materials (6 types)

New food additives (12 types)

New food-related products (5 types)