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Analysis on the Application and Approval of New Food Raw Materials (Novel Food) in 2023

from CIRS by

In 2023, the National Health Commission of the People’s Republic of China (NHC) issued five announcements ( No. 1 of 2023, No. 3 of 2023, No. 5 of 2023, No. 8 of 2023 , and No. 10 of 2023 ) regarding “Three New Food”. A total of 74 products, including new food raw materials (novel food), new food additives, and food-related products (new food contact substances) have been approved, 12 of which are new food raw materials (novel food) , namely Leuconostoc pseudomesenteroides, blueberry anthocyanins, rye pollen, yellowhorn seed kernel, yellowhorn leaf, peach gum, tiger nut, Leuconostoc mesenteroides subsp. Cremoris, pyrroloquinoline quinone disodium (PQQ) salt, catechins, yerba mate, and yeast protein.

China,Food,Material,Novel,Application,Registration

Furthermore, according to the official announcements issued by the NHC and the China National Center for Food Safety Risk Assessment (CFSA), throughout 2023:

  • 22 new food raw materials applications were accepted;
  • 17 new food raw materials were issued for public comment;
  • 4 products were rejected for approval; and
  • 5 substances were included in the termination review list.

CIRS has summarized the acceptance and approval status of new food raw materials in China in 2023 as follows:

1. List of accepted new food raw materials in 2023 (22 types)

In 2023, NHC accepted the applications for 22 new food raw materials, with the majority being domestically produced products and a minority being imported products. The detailed technical review status is listed in the table below:

S.N.

Date of acceptance

Acceptance code

Name

Technical review status

1

2023.02.02

卫食新申字(2023)第0001号

Pyrroloquinoline quinone disodium (PQQ) salt

2023.10.07

Approved

2

2023.02.15

卫食新申字(2023)第0002号

Pleurotus eryngii mycelium

2023.06.20

Rejected for approval

3

2023.03.09

卫食新申字(2023)第0003号

Bacillus subtilis

2023.08.28

Issued for public comments

4

2023.03.24

卫食新申字(2023)第0004号

Fermented mycelial proteins of Fusarium venenatum strain TB01

2023.06.20

Rejected for approval

5

2023.04.06

卫食新申字(2023)第0005号

N-Acetylglucosamine

Not issued for public comments yet

6

2023.05.10

卫食新申字(2023)第0006号

Pyrroloquinoline quinone disodium (PQQ) salt

Not issued for public comments yet

7

2023.07.10

卫食新申字(2023)第0007号

Bifidobacterium animalis subsp. Lactis XLTG11

Not issued for public comments yet

8

2023.07.19

卫食新申字(2023)第0008号

Stevia rebaudiana

Terminated the review

9

2023.07.25

卫食新申字(2023)第0009号

D-psicose

Not issued for public comments yet

10

2023.07.25

卫食新进申字(2023)第0001号

Green oat extract

2023-10-07

Rejected for approval

11

2023.08.28

卫食新申字(2023)第0010号

Drumstick Dendrobium flower

Not issued for public comments yet

12

2023.08.28

卫食新申字(2023)第0011号

Egg Yolk Lecithin;

Egg Phospholipids

Not issued for public comments yet

13

2023.09.04

卫食新申字(2023)第0012号

Theanine

Not issued for public comments yet

14

2023.09.04

卫食新申字(2023)第0013号

Nannochloropsis gaditana Extract

Not issued for public comments yet

15

2023.09.06

卫食新申字(2023)第0014号

L-alpha-Glycerylphosphorylcholine

2023.12.22

Issued for public comments

16

2023.09.07

卫食新申字(2023)第0015号

Stevia rebaudiana Extract

Not issued for public comments yet

17

2023.09.11

卫食新进申字(2023)第0002号

Leuconostoc pseudomesenteroides

2023.12.22

Issued for public comments

18

2023.09.12

卫食新申字(2023)第0016号

Golden tea flowers

Terminated the review

19

2023.09.28

卫食新进申字(2023)第0003号

Corn fermentation

Not issued for public comments yet

20

2023.10.23

卫食新申字(2023)第0017号

Malania oleifera oil

Not issued for public comments yet

21

2023.11.16

卫食新进申字(2023)第0004号

Bifidobacterium longum biovar infantis M-63

Not issued for public comments yet

22

2023.11.22

卫食新进申字(2023)第0005号

Oat green extract

Not issued for public comments yet

2. List of new food raw materials issued for public comments in 2023 (17 types)

In 2023, 17 new food raw materials have passed the technical review of CFSA and were issued for public comments. (Only the 6 raw materials that are still in the public consultation stage and have not been approved yet are presented below. See Part 3 for detailed information on the other 11 approved raw materials including blueberry anthocyanins.).

Details are as follows:

(1) Eggshell membrane extract (Draft announcement)

Name

Eggshell membrane extract

Basic information

Source: Eggshell membrane

Brief introduction of the production process

Prepared through eggshell-membrane separation, sterilization, hydrolysis, mixing, drying, grinding, and other processes by using eggshell as the raw material.

Recommended intake

≤500 mg/day

Other information

1. The labels and instructions shall bear a statement that they should not be consumed by infants, pregnant women, lactating women and people with an allergy to eggs, along with the recommended intake.

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

Acceptance date

Accepted on September 17, 2021. The acceptance code is 卫食新进申字(2021)第0006号.

Acceptance name: 蛋壳膜粉

Issued date

Passed the technical review and issued for public comments on January 12, 2023

(2) (3R,3'S)-β,β-carotene-3,3'-Diol (Draft announcement)

Name

(3R,3'S)-β,β-carotene-3,3'-Diol

Basic information

Source: Tagetes Erecta L.

CAS number: 31272-50-1

Molecular formula: C40H56O2

Molecular weight: 568.88

Structure:

Brief introduction of the production process

Prepared through dehydration, crushing, extraction, isomerization, purification, drying processes, and other processes by using Tagetes Erecta L as the raw material.

Recommended intake

≤8 mg/day (count as (3R,3'S)-β,β-carotene-3,3'-Diol)

Other information

Application scope and maximum levels:

Milk and dairy products (10 mg/kg); beverages: 160 mg/kg for liquid beverages ≤50 mL, 16 mg/kg for liquid beverages of 51-500 mL; solid beverages are converted according to the mass of liquid after preparation; bakery food (20 mg/kg); candy (3g/kg); ready-to-eat cereals (15 mg/kg); frozen beverages (30 mg/kg), excluding infants and young children food.

Food safety indicators shall meet the requirements as outlined in the draft announcement.

Acceptance date

Accepted on March 17, 2022. The acceptance code is 卫食新申字(2022)第0002号.

Issued date

Passed the technical review and issued for public comments on August 28, 2023.

(3) Pichia kluyver (Draft announcement)

Name

Pichia kluyver

Other information

Being included in the List of Strains that Can Be Used in Food and approved for use in the fermentation processing of fermented wine, fruit and vegetable juices, and tea drinks (excluding infants and young children foods). The labels and instructions shall bear a statement of the scope of use.

Food safety indicators shall meet the requirements as outlined in the draft announcement.

Acceptance date

Accepted on December 5, 2022. The acceptance code is 食新进申字(2022)第0006号.

Issued date

Passed the technical review and issued for public comments on August 28, 2023.

(4) Bacillus subtilis DE111 (Draft announcement)

Name

Bacillus subtilis DE111

Other information

  1. Being included in the List of Strains that Can Be Used in Food.
  2. Food safety indicators shall meet the requirements as outlined in the draft announcement.

Acceptance date

Accepted on March 9, 2023. The acceptance code is卫食新申字(2023)第0003号.

Acceptance name: 枯草芽孢杆菌

Issued date

Passed the technical review and issued for public comments on August 28, 2023.

(5) L-alpha-Glycerylphosphorylcholine (Draft announcement)

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

The labels and instructions shall bear a statement that they should not be consumed by infants, pregnant women, and lactating women, along with the recommended intake.

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

Acceptance date

Accepted on September 6, 2023. The acceptance code is 卫食新申字(2023)第0014号.

Issued date

Passed the technical review and issued for public comments on December 22, 2023.

(6) Leuconostoc pseudomesenteroides (Draft announcement)

Name

Leuconostoc pseudomesenteroides

Other information

1. Included in the List of Strains that Can Be Used in Food. The applicable scope includes fermented milk, flavored fermented milk, cheese, fermentation milk drinks and lactobacillus drinks (non-solid drinks), cream, butter and anhydrous milkfat, excluding infants and young children food.

2. Food safety indicators shall meet the requirements as detailed in the draft announcement.

Acceptance date

Accepted on September 11, 2023. The acceptance code is 卫食新进申字(2023)第0002号.

Acceptance name: 假肠膜明串珠菌

Issued date

Passed the technical review and issued for public comments on December 22, 2023.

3. List of approved new food raw materials in 2023 (12 types)

There were 12 new food raw materials approved in 2023, including 2 strains that can be used in food, namely Leuconostoc pseudomesenteroides and Leuconostoc mesenteroides subsp. cremoris. The detailed approval information for each product is as follows:

(1) Leuconostoc pseudomesenteroides

Name

Leuconostoc pseudomesenteroides

Other information

Included in the List of Strains that Can Be Used in Food. The applicable scope includes fermented milk, flavored fermented milk, cheese, fermentation milk drinks and lactobacillus drinks (non-solid drinks), excluding infants and young children's food.

Food safety indicators shall meet the relevant requirements as detailed in the announcement.

Acceptance date

Accepted on April 19, 2021. The acceptance code is 卫食新进申字(2021)第0002号.

Acceptance name: 假肠膜明串珠菌

Issued date

Passed the technical review and issued for public comments on June 29, 2022.

Approved date

Officially approved on March 2, 2023 according to Notice No.1, 2023.

(2) Blueberry anthocyanins

Name

Blueberry anthocyanins

Basic information

Source: Blueberry derived from Vaccinium corymbosum L.

Brief introduction of the production process

Prepared through enzymolysis, water extraction, purification, concentration, drying and other processes, using blueberries as raw materials.

Recommended intake

≤800 mg/day

Other information

Applicable scope and maximum usage level:

Milk and dairy products (modified milk and flavored fermented milk: 0.8 g/kg; formulated milk powder shall be converted according to the liquid volume after preparation; cheese, process(ed) cheese, cheese products and condensed milk shall be converted according to the raw milk usage amount); beverages (0.8 g/kg; solid beverages shall be converted according to the liquid volume after preparation); jelly (14 g/kg), cocoa products, chocolates and chocolate products (including chocolate and chocolate products with cocoa butter substitute) (14 g/kg ); candy (40 g/kg); frozen beverages (8 g/kg); bakery foods (4 g/kg); alcoholic beverages (4 g/kg).

The labels and instructions shall bear a statement that they should not be consumed by infants, pregnant women, and lactating women, along with the recommended intake.

Food safety indicators shall meet the relevant requirements as detailed in the announcement.

Acceptance date

Accepted on October 26, 2021. The acceptance code is 卫食新申字(2021)第0012号.

Acceptance name: 蓝美1号蓝莓提取物

Issued date

Passed the technical review and issued for public comments on January 12, 2023.

Approved date

Officially approved on May 6, 2023 according to Notice No. 3, 2023.

(3) Rye pollen

Name

Rye pollen

Basic information

Source: Secale Cereale L.

Brief introduction of the production process

Prepared through pollen collection, drying, separation and other processes by using rye as the raw material.

Recommended intake

≤1.5 g/day

Other information

The labels and instructions shall bear a statement that they should not be consumed by infants, pregnant women and lactating women, along with the recommended intake.

Food safety indicators shall meet the relevant requirements as detailed in the announcement.

Acceptance date

Accepted on October 25, 2021. The acceptance code is 卫食新进申字(2021)第0008号.

Issued date

Passed the technical review and issued for public comments on January 12, 2023.

Approved date

Officially approved on May 6, 2023 according to Notice No. 3, 2023.

(4) Yellowhorn seed kernel

Name

Yellowhorn seed kernel

Basic information

Source: Seeds of Xanthoceras sorbifolium Bunge

Brief introduction of the production process

Prepared through drying, magnetic separation, dehulling, screening, and other processes by using the seeds of Xanthoceras sorbifolium Bunge as raw materials.

Other information

The labels and instructions shall bear a statement that they should not be consumed by infants, pregnant women, and lactating women, along with the recommended intake.

Refer to the announcement for detailed quality requirements. Food safety indicators shall comply with the current national food safety standards for nuts and seeds.

Acceptance date

Accepted on March 29, 2021. The acceptance code is 卫食新申字(2021)第0006号.

Issued date

Passed the technical review and issued for public comments on March 10, 2023.

Approved date

Officially approved on August 1, 2023 according to Notice No. 5, 2023.

(5) Yellowhorn leaf

Name

Yellowhorn leaf

Basic information

Source: Young leaves of Xanthoceras sorbifolium Bunge

Brief introduction of the production process

Prepared through fixation, rolling, drying, and other processes by using the young leaves of Xanthoceras sorbifolium Bunge as raw materials.

Recommended intake

≤6 g/day

Other information

The labels and instructions shall bear a statement that they should not be consumed by infants, pregnant women, and lactating women, along with the recommended intake.

Edible method: brewing

Food safety indicators shall meet the relevant requirements as detailed in the announcement.

Acceptance date

Accepted on June 6, 2022. The acceptance code is 卫食新申字(2022)第0006号.

Issued date

Passed the technical review and issued for public comments on March 10, 2023.

Approved date

Officially approved on August 1, 2023 according to Notice No. 5, 2023

(6) 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 g/day

Other information

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.

Food safety indicators shall meet the relevant requirements as detailed in the announcement.

Acceptance date

Accepted on May 7, 2022. The acceptance code is 卫食新申字(2022)第0004号.

Issued date

Passed the technical review and issued for public comments on April 23, 2023.

Approved date

Officially approved on October 7, 2023 according to Notice No. 8, 2023

(7) 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.

Refer to the announcement for detailed quality specifications.

Acceptance date

Accepted on September 5, 2022. The acceptance code is 卫食新申字(2022)第0010号.

Issued date

Passed the technical review and issued for public comments on April 23, 2023.

Approved date

Officially approved on October 7, 2023 according to Notice No. 8, 2023.

(8) 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 use in the fermentation processing of milk and dairy products, fruit and vegetable products, and grain products (excluding infants and young children food).
  2. Food safety indicators shall meet the relevant requirements as detailed in the announcement.

Acceptance date

Accepted on November 23, 2021. The acceptance code is 卫食新申字(2021)第0014号。

Issued date

Passed the technical review and issued for public comments on April 23, 2023.

Approved date

Officially approved on October 7, 2023 according to Notice No. 8, 2023.

(9 ) Pyrroloquinoline quinone disodium (PQQ) salt

Name

Pyrroloquinoline quinone disodium (PQQ) salt

Basic information

CAS: 122628-50-6

Molecular formula: C14H4N2Na2O8

Molecular weight: 374.17

Structure:

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

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 lactating women, along with the recommended intake.
  3. The methods for detecting the content of pyrroloquinoline quinone disodium (PQQ) salt are given in Appendix A of NHC Notice No. 2022.
  4. Food safety indicators and quality specifications shall meet the relevant requirements as detailed in the announcement.

Acceptance date

Accepted on February 2, 2023. The acceptance code is 卫食新申字(2023)第0001号.

Issued date

Passed the technical review and issued for public comments on April 23, 2023.

Approved date

Officially approved on October 7, 2023 according to Notice No. 8, 2023.

(10) Catechins

Name

Catechins

Basic information

Source: Camellia sinensis (L.) O. Ktze.

Brief introduction of the production process

Prepared through alcohol extraction, concentration, separation, extraction, enzymolysis, concentration, drying, and other processes using tea leaves as raw materials.

Recommended intake

≤300 mg/day (count as the total catechins)

Other information

Applicable scope and maximum usage level: beverages (0.6 g/kg, solid beverages shall be converted according to the mass of liquid after preparation); candy (0.2 g/kg).

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.

When being used and consumed simultaneously with EGCG as specified in Notice No.17 of 2010, the recommended total intake is set at ≤300 mg/day (counted as the total catechins).

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

Acceptance date

Accepted on October 27. The acceptance code is 卫食新申字(2021)第0013号.

Acceptance name: 微晶复合儿茶素

Issued date

Passed the technical review and issued for public comments on January 12, 2023.

Approved date

Officially approved on December 1, 2023 according to Notice No.10, 2023.

(11) Yerba mate

Name

Yerba mate

Basic information

Source: Leaves of Ilex paraguariensis A.St.-Hil.

Brief introduction of the production process

Prepared through picking, roasting, chopping, drying, and other processes using leaves of Ilex paraguariensis A.St.-Hil. as raw materials.

Other information

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.

Edible method: brewing.

Food safety indicators shall meet the requirements as specified in the draft announcement.

Acceptance date

Accepted on November 2, 2022. The acceptance code is 卫食新进申字(2022)第0004号.

Acceptance name: 马黛茶叶

Issued date

Passed the technical review and issued for public comments on June 21, 2023.

Approved date

Officially approved on December 1, 2023 according to Notice No.10, 2023.

(12) Yeast protein

Name

Yeast protein

Main component

Yeast protein

Brief introduction of the production process

The bacterial raw material is obtained through breeding, fermenting, and centrifuging using Saccharomyces Cerevisiae as the strain basis. It is then prepared through nucleic acid removal, centrifugation enzymolysis, extraction, purification, separation, sterilization, drying, and other processes.

Other information

The labels and instructions shall bear a statement indicating that they should not be consumed by infants, pregnant women, and lactating women.

Food safety indicators shall meet the relevant requirements as specified in the announcement.

Acceptance date

Accepted on July 26, 2022. The acceptance code is 卫食新申字(2022)第0008号.

Issued date

Passed the technical review and issued for public comments on March 10, 2023.

Approved date

Officially approved on December 1, 2023 according to Notice No.10, 2023.

4. Raw materials included in the List of Termination of Review (5 types)

In 2023, 5 raw materials were included in the list of termination reviews. Currently there are 73 products on the list.

No.

Acceptance code

Name

1

卫食新申字(2022)第0007号

Fructo-oligosaccharides (from brown sugar)

2

卫食新进申字(2021)第0009号

Chicken concentrated powder

3

卫食新申字(2021)第0015号

Coreopsis tinctoria

4

卫食新申字(2023)第0008号

Stevia rebaudiana

5

卫食新申字(2023)第0016号

Golden tea flowers

5. Raw materials rejected for approval in 2023 (4 types)

In 2023, 4 products were rejected for approval by NHC including two microorganism fermented protein products (domestic) accepted in 2023, one plant extract product (imported), and Periploca sepium Bunge leaves (domestic) accepted in 2022. Details are as follows:

No.

Acceptance date

Acceptance code

Name

Review process/conclusion

1

2022.08.11

卫食新申字(2022)第0009号

Periploca sepium Bunge leaves

2022.10.18 Delivered a notification of review opinion on the new food raw material;

2023.02.07 Issued a decision of not granting administrative permission.

2

2023.02.15

卫食新申字(2023)第0002号

Pleurotus eryngii mycelium

2023.04.17 Delivered a notification of review opinion on the new food raw material;

2023.06.20 Issued a decision of not granting administrative permission.

3

2023.03.24

卫食新申字(2023)第0004号

Fermented mycelial proteins of Fusarium venenatum strain TB01

2023.04.17 Delivered a notification of review opinion on the new food raw material;

2023.06.20 Issued a decision of not granting administrative permission.

4

2023.07.26

卫食新进申字(2023)第0001号

Green Oats extract

2023.06.20 Delivered a notification of review opinion on the new food raw material;

2023.10.07 Issued a decision of not granting administrative permission.

6. Conclusion

It can be observed through the analysis of the application cycle of this year that, for the majority of raw materials, the process from being accepted to collecting public comments can be completed within one year, and for some, the cycle can be shortened to six months. Among the 12 approved new food raw materials, three-quarters of them can complete the whole process within two years. It can be seen that most enterprises have made sufficient preparations during the application process. However, there have also been cases of some raw materials not being approved. Therefore, it is crucial for enterprises intending to apply to conduct a comprehensive feasibility analysis at the beginning and make full preparations for documentation. This not only facilitates the relevant departments in advancing the work and shortening the review cycle, while also allowing companies to save time and costs.

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Note: There may be omissions and errors in the data and statistics. The data in this article is for reference only, please refer to the official information published by government departments.

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