Analysis on the Registration Application of New Food Raw Material (Novel Food) in China in 2022

Name

Arabinoxylan

Basic information

Structure: arabinoxylan structure (fragment)

CAS number: 9040-27-1

Brief introduction of the production process

Prepared through pretreatment, edible alkali extraction, desalkali concentration, neutralization precipitation, washing and purification, drying, and other processes by using sugarcane, wheat bran, corn skin, and other grains as raw materials.

Recommended intake

≤15 grams per day (g/day) (with arabinoxylan content of 85 g/100 g, the content exceeding the actual content shall be converted)

Other information

1. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions.

2. Quality specifications and food safety indicators are detailed in the draft announcement.

Issued date

14/03/2022

CFSA Collected Public Comments on Arabinoxylan

Latin Name

Leuconostoc pseudomesenteroides

Other information

1. Scope of use: fermented milk, cheese, fermented milk-containing drinks, and lactic acid bacteria drinks.

2. Approved as edible fungi, the scope of use does not include infant food.

3. Food safety indicators should meet the relevant standards of China.

Issued date

29/06/2022

CFSA Collected Public Comments on Leuconostoc pseudomesenteroides

Acceptance date

19/04/2021, 卫食新进申字(2021)第0002号

Name

Calcium β-hydroxy-β-methyl butyrate (CaHMB)

Basic information

Constitutional formula:

Molecular formula: C10H18O6Ca∙H2O

Molecular weight: 292

Brief introduction of the production process

Prepared through oxidation synthesis, acidification, extraction, neutralization reaction, centrifugation, drying, and other processes by using sodium hypochlorite, diacetonol, hydrochloric acid, ethyl acetate, ethanol, calcium hydroxide as the main raw materials.

Recommended intake

≤ 6 g/day

Other information

1. Scope of use: beverages, milk, and dairy products, cocoa products, chocolate and chocolate products, confectionery, baked goods, sports nutrition food, and formula food for special medical use.

2. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions with consumption limits.

3. See the draft announcement for quality specifications and food safety indicators.

Issued date

21/10/2022

CFSA Collected Public Comments on Calcium β-hydroxy-β-methyl butyrate (CaHMB)

Acceptance date

15/06/2020, 卫食新申字(2020)第0003号

Name

Kanzan flower

Basic information

Source: The flowers of Cerasus serrulata ”Sekiyama". The flowering period is more than 3/4 of the buds to full bloom.

Other information

1. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions.

2. Food safety indicators shall be implemented in accordance with the provisions of other vegetable products.

Acceptance date

25/01/2021, 卫食新申字(2021)第0001号

Date of soliciting comment

17/08/2021

CFSA Collected Public Comments on Kanzan flower and Pyrroloquinolinequinonedisodium (PQQ) salt

Approved date

01/03/2022, officially approved by the announcement No.1 of 2022

Name

Pyrroloquinolinequinonedisodium (PQQ) salt

Basic information

CAS: 122628-50-6

The formula is: C₁₄H₄N₂Na₂O₈

Molecular weight: 374.17

Chemical structural formula:

Brief introduction of the production process

Prepared through coupling ring formation reaction, quinoline ring formation, oxidation reaction and ester hydrolysis reaction, refining, and other processes by using 6-amino-5-methoxy-1H-Indo-2-carboxyl ester and 2-oxidized prenenyl dimethyl ester as the main raw materials.

Recommended intake

≤20 mg/day

Quality requirement

Shape and properties

Red-brown powder

Priroroquinone (dry base), g/100 g                                   ≥

98.0

Moisture, g/100 g                                                              ≤

12.0

Other information

1. Scope and maximum use: beverage (40 mg/kg, solid beverage is converted according to the liquid volume after preparation).

2. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions.

3. The method for the determination of the content of pyrroloquinoline quinonedi sodium salt and two impurities (3-chloro-4,5-dioxo-4,5-dihydro-1H-pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid and 4-nitro-5-methoxy-1H-pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid) is described in the bulletin.

4. Food safety indicators shall comply with the following provisions:

Lead (Pb), mg/kg                                                              ≤

0.5

Arsenic (As), mg/kg                                                          ≤

1.0

Cadmium (Cd), mg/kg                                                      ≤

0.1

Mercury (Hg), mg/kg                                                        ≤

0.1

3-Chloro-4,5-dioxo-4,5-dihydro-1H-pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid, g/100g                                             ≤

0.8

4-Nitro-5-methoxy-1H-pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid, g/100g                                                                 ≤

0.5

Acceptance date

08/03/2021, 卫食新申字(2021)第0004号

Issued date

17/08/2021

CFSA Collected Public Comments on Kanzan flower and Pyrroloquinolinequinonedisodium (PQQ) salt

Approved date

01/03/2022, officially approved by the announcement .1 of 2022

Latin Name

Chlamydomonas reinhardtii

Basic information

Species: Chlamydomonas family, Chlamydomonas

Brief introduction of the production process

Made by algal species cultivation, fermentation tank heterotrophic expansion cultivation, drying, and other processes.

Quality requirement

Shape and properties

Green powder

Protein content

≥30.0%

Crude polysaccharide content

≥10.0%

Other information

1. The scope of use does not include infant food.

2. Food safety indicators shall be implemented in accordance with the current national food safety standard on algae and algae products.

Acceptance date

13/09/2021, 卫食新申字(2021)第0011号

Issued date

08/12/2021

CFSA Collected Public Comments on Chlamydomonas reinhardtii

Approved date

11/05/2022, officially approved by the announcement No.2 of 2022

Latin Name

Bifidobacterium longum subsp .longum BB536

Other information

1. Approved for use in infant food.

2. Food safety indicators should meet the relevant standards of China.

Acceptance date

18/05/2021 , 卫食新进申字(2021)第0003号

Issued date

01/11/2021

CFSA Collected Public Comments on Bifidobacterium longum subsp .longum BB536

Approved date

11/05/2022, officially approved by the announcement No.2 of 2022

Name

Sugarcane Polyphenols

Brief introduction of the production process

Prepared by using sugarcane as raw material through crushing, filtration, extraction, removing excess sugar and salt, using water and ethanol as an extraction solvent to be transferred into powder by filtration, vacuum concentration, ion exchange, spray drying, and other processes; or to be transferred into liquid by filtration, vacuum distillation, and other processes.

Recommended intake

≤ 1 g/day (powder); ≤ 10 g/day (liquid)

The recommended amount of powder (polyphenol content: 200 g/kg) is 1 g/day, and that of liquid (polyphenol content: 14.8 g/kg) is 10 g/day. When the polyphenol content exceeds the above, it shall be converted according to the actual content.

Other information

1. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions.

2. Quality specifications and food safety indicators are detailed in the announcement.

Acceptance date

18/05/2021, 卫食新申字(2021)第0008号,

Name of acceptance: Sugarcane Extract

Issued date

01/11/2021

CFSA Collected Public Comments on Bifidobacterium longum subsp .longum BB536

Approved date

11/05/2022 officially approved, the announcement is No.2 of 2022

S/N

Product Name

Review Opinions

Acceptance Date and Number

1

Penthorum chinense Pursh

The NHC has approved penthorum chinense pursh as a new food raw material for bubble drinking in Announcement No.4 of 2020, and the application scope is applying for expanding to the beverage. Based on the safety assessment data provided, it was agreed to use the beverage and recommended to terminate the review. Except for the edible form, it shall be implemented in accordance with No.4 of 2020.

17/01/2022, 卫食新申字(2022)第0001号

2

Gua Lou Zi

Gua Lou Zi has been included in the "National Food Safety Standard Nuts and Seed Food" GB 19300, used as food raw materials according to the management of nuts and seed food, it was recommended to terminate the review.

24/04/2022, 卫食新申字(2022)第0003号

3

Sialic acid

Prepared through bacterial fermentation, filtration, sterilization, hydrolysis, ultrafiltration, decolorization, decontamination, nanofiltration, concentration, purification, drying, crushing, sieving, and other processes by Escherichia coli (strain No. CASOV-09) as the fermenting strain. The production process is essentially the same as that of Sialic acid approved for the announcement (formerly Health and Welfare Commission Announcement No. 7 of 2017), which shows substantial equivalence. Other requirements are implemented in accordance with the relevant content of the published announcement of Sialic Acid, and food safety indicators are implemented in accordance with the following: Aflatoxin B1≤5 micrograms per kilogram (μg/kg), Lead (calculated as Pb) ≤0.8 milligrams per kilogram (mg/kg), Mercury (calculated as Hg)≤0.2 mg/kg, Arsenic (calculated as As)≤0.4 mg/kg, total colony count ≤1000 CFU/g, Coliform ≤0.6 MPN/g, Mould≤100 CFU/g, Yeast≤100 CFU/g, Salmonella 0/25 g, Staphylococcus aureus 0/25 g.

06/04/2021, 卫食新申字(2021)第0007号

S/N

Product Name

Acceptance Date

Acceptance Number

Review Process / Conclusion

1

Mycelium Oxalicum Powder

The acceptance date was not reached

卫食新进申字(2019)第0002号

18/02/2022 Issuance of a decision not to grant administrative permission

2

Isomaltodextrin

12/04/2021

卫食新进申字(2021)第0001号

01/06/2021 Delivering a notification of review opinion on the new food raw material

22/04/2022 Issuance of a decision not to grant administrative permission

3

Maize ferments

19/07/2021

卫食新进申字(2021)第0004号

30/07/2021 Delivering a notice on delaying review for the new food raw material

08/10/2021 Delivering a notice on delaying review for the new food raw material

02/12/2021 Delivering a notice on delaying review for the new food raw material

17/02/2022 Delivering a notice on delaying review for the new food raw material

26/04/2022 Issuance of a decision not to grant administrative permission

4

Pine (Pinus massoniana Lamb.) needle

23/05/2022

卫食新申字(2022)第0005号

27/06/2022 Delivering a notification of review opinion on the new food raw material

26/10/2022 Issuance of a decision not to grant administrative permission