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China Approves New Food Raw Materials, Additives, and Food-Related Products

from CIRS by

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

  1. 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.
  2. 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

  1. 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).
  2. 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

  1. Application scope and maximum usage level: beverages (40 mg/kg, solid beverages are converted according to the mass of liquid after preparation).
  2. 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.
  3. Test methods for PQQ salt are given in the Appendix.
  4. 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.)a and (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

-

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

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

25067-21-4

Coating and coating film

Appropriate level

2

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

20

(Count as the coating formula)

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