China Approves New Food Raw Materials, Additives, and Food-Related Products - Regulatory News - Food & Food Contact Materials

On October 7, the National Health Commission of the People’s Republic of China (NHC) issued an announcement (No. 8 of 2023) on the approval of 15 “Three New Foods”, including four new food raw materials, six new food additives, and five food-related products. Details are as follows:

New food raw materials (four types)

1. Peach gum

Name	Peach gum
Basic information	Source: Prunus persica (L.) Batsch
Brief introduction of the production process	Prepared through picking, sorting, airing, cleaning, drying, and other processes by using the gum secreted from Prunus persica (L.) Batsch.
Recommended intake	≤30 grams per day (g/day)
Quality requirements	Crude polysaccharide, grams per 100g (g/100 g)	≥ 60
	Moisture, g/100 g	≤ 15
	Ash, g/100 g	≤ 2
Other information	The labels and instructions shall bear a statement indicating that they should not be consumed by infants, pregnant women, and breastfeeding women, along with the recommended intake. Food safety indicators must meet the following requirements:
	Lead (Pb), milligrams per kilogram (mg/kg)	≤ 0.5
	Arsenic (As), mg/kg	≤ 0.5
	Ochratoxin A, μg/kg	≤ 5.0
	Coliforms, CFU/g	≤ 100
	Mould and Yeast, CFU/g	≤ 150
	Staphylococcus aureus, /25g	0
	Salmonella, /25g	0

2. Tiger nut

Name

Tiger nut

Basic information

Source: Cyperus esculentus L. var. sativus Boeck.

Edible part: stem tubers

Other information

Food safety indicators shall comply with the current national food safety standard for nuts and seeds.

3. Leuconostoc mesenteroides subsp. cremoris

Name	Leuconostoc mesenteroides subsp. cremoris
Other information	Being included in the List of Strains that Can be Used in Food, and approved for the use in fermentation processing of milk and dairy products, fruit and vegetable products, and grain products (excluding infants and young children food). Food safety indicators must meet the following requirements:
	Pb, (on dry basis), mg/kg	≤ 1.0
	As, (on dry basis), mg/kg	≤ 1.5
	Salmonella, /25g (mL)	0
	Staphylococcus aureus, /25g (mL)	0
	Listeria monocytogenes, /25g (mL)	0

4. Pyrroloquinoline quinone disodium (PQQ) salt

Name	Pyrroloquinoline quinone disodium (PQQ) salt
Basic information	CAS: 122628-50-6 Molecular formula: C₁₄H₄N₂Na₂O₈ Structure: Molecular weight: 374.17
Brief introduction of the production process	Prepared through fermentation, extraction, purification, crystallization, drying, and other processes by using Methylovorus glucosotrophus as the production strain.
Recommended intake	≤20 mg/day
Quality requirements	Property:	Reddish brown powder
	Pyrroloquinoline quinone disodium (PQQ) salt content (on dry basis), g/100 g	≥ 98.0
	Moisture, g/100 g	≤ 12.0
Other information	Application scope and maximum usage level: beverages (40 mg/kg, solid beverages are converted according to the mass of liquid after preparation). The labels and instructions shall bear a statement indicating that they should not be consumed by infants, pregnant women, and breastfeeding women, along with the recommended intake. Test methods for PQQ salt are given in the Appendix. Food safety indicators must meet the following requirements:
	Pb, mg/kg	≤ 0.5
	As, mg/kg	≤ 1.0
	Cd, mg/kg	≤ 0.1
	Hg, mg/kg	≤ 0.1
	Total plate count, CFU/g	≤ 1000
	Coliforms, MPN/g	≤ 3.0
	Mould and Yeast, CFU/g	≤ 100
	Staphylococcus aureus, /25g	0
	Salmonella, /25g	0

New food additives (six types)

1. New food enzyme (one type)

No.	Enzyme	Source	Donor
1	Serine protease	Bacillus licheniformis	Nocardiopsis prasina

* The quality specifications of the enzyme shall meet the requirements in the National Food Safety Standard - Food Additives, Enzymes (GB 1886.174).

2. New food nutrition enhancers (three types)

(1) Name: Magnesium lactate

Application scope and maximum usage level: It shall be consistent with the requirements of magnesium in the National Food Safety Standard – Standard for the Use of Food Nutrition Enhancer (GB 14880).

Quality specifications: Applicable to the new food nutrition enhancer magnesium lactate, which is prepared through the reaction of lactic acid and magnesium oxide (or magnesium carbonate).

(2) Name: 2’-fucosyllactose, 2’-FL

Application scope and maximum usage level:

Category number	Food name/category	Usage level	Note
01.03.02	Modified milk powder (limited to milk powder for children)	0.7-2.4 g/L (Count as the state of ready to eat, for powdery products, the level of use should be increased by times of brewing)	When mixed with Lacto-N-neotetraose (LNnT), oligo-galactose, oligofructose, polyfructose and raffinose, the total amount of 2'-fucosyllactose must not exceed 64.5 (g/kg).
13.01.01	Infant formula foods
13.01.02	Older infants and young children formula foods
13.01.03	Infant formula foods for special medical purposes

Quality specifications: Applicable to the new food nutrition enhancer 2’-fucosyllactose (2’-FL), which is prepared through fermentation, purification, drying, and other processes using lactose as a raw material. The production strain of 2’-FL should undergo a safety assessment and comply with the requirements outlined in Appendix C.

Appendix C Information on the production strain of 2’-fucosyllactose

Nutrition enhancer	Source	Donor
2’-fucosyllactose	Coli K12 DH1 MDO	(Helicobacter spp.)^a
	E. coli K-12 MG1655	(Helicobacter spp.)^a
	E. coli BL21 (DE3)	(Neisseria spp.)^a

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

(3) Name: Lacto-N-neotetraose, LNnT

Application scope and maximum usage level:

Category number	Food name/category	Usage level	Note
01.03.02	Modified milk powder (limited to milk powder for children)	0.2-0.6 g/L (Count as the state of ready to eat, for powdery products, the level of use should be increased by times of brewing)	When mixed with 2’-fucosyllactose, oligo-galactose, oligofructose, polyfructose and raffinose, the total amount must not exceed 64.5 (g/kg).
13.01.01	Infant formula foods
13.01.02	Older infants and young children formula foods
13.01.03	Infant formula foods for special medical purposes

Quality specifications: Applicable to the new nutrition enhancer Lacto-N-neotetraose (LNnT), which is prepared through fermentation, purification, drying, and other processes using lactose as a raw material. The production strain of LNnT should undergo a safety assessment and comply with the requirements outlined in Appendix D.

Appendix D Information on the production strain of Lacto-N-neotetraose

Nutrition enhancer	Source	Donor
Lacto-N-neotetraose	E. coli K-12 DH1 MDO	(Neisseria spp.)^aand (Helicobacter spp.)^b

^a is the donor of β-1,3-N-acetylglucosamine transferase

^b is the donor of β-1,4-galactosyltransferase

3. New food additives with expanded scope (two types)

No.	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Note
1	Calcium lactate	Stabilizer and coagulant, acidity regulator	04.02.02.03	Pickled vegetables	10.0	-
1	Calcium lactate	Stabilizer and coagulant, acidity regulator	04.02.02.04	Canned vegetables	3.0	-
2	Sanzan gum	Thickener, stabilizer, and coagulant	01.01.03	Modified milk	0.5	-
			14.03.03	Mixed protein drinks	0.75	Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.
			14.08	Flavored drinks	0.5

New food-related products (five types)

1. Food contact additives with expanded scope (three types)

No.	Name	CAS number	Application scope	Maximum level (%)
1	C.I. pigment black 7; Carbon black	1333-86-4	Plastic: PEEK	0.5
2	Copolymer of acrylamide with methacryloyloxyethyltrimethylammonium chloride, itaconic acid, and N, N '- methylene bisacrylamide	214495-32-6	Paper and paperboard	1.5 (Count as the dry weight)
3	2- (Vinyloxy) -1,2,3-propanecarboxylic acid tributylester	77-90-7	Ink with indirect contact with food	10

2. New food contact resin (two types)

No.

Name

CAS number

Range of application

Maximum level (%)

1,4-Benzenedicarboxylic acid, polymer with sebacic acid and 1,2-ethanediol

25067-21-4

Coating and coating film

Appropriate level

Polymers of methacrylic acid with butyl methacrylate, ethyl acrylate and methyl methacrylate, and polymers of hydroquinone with 4,4-methylenebis (2,6-dimethylphenol) and chloromethylepoxyethane with N, N-dimethylethanolamine

Coating and coating film

(Count as the coating formula)

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