Analysis of the Application and Approval Status of New Food Raw Materials in the First Half of 2024

As of June 30, 2024, the National Health Commission (NHC) issued A nnouncement No. 2 of 202 4, approving a total of 23 products, including new food raw materials (novel food), new food additives, and new food-related products (new food contact substances). Notably, 6 new food raw materials were approved: Dendrobium protocorm, Meso-zeaxanthin, Pichia kluyveri, Bacillus subtilis DE111, L-alpha-Glycerylphosphorylcholine, and Leuconostoc pseudomesenteroides.

In addition, according to information released by the NHC and the China National Center for Food Safety Risk Assessment (CFSA), in the first half of 2024, applications for 16 new food raw materials were accepted, 7 draft announcements were issued for public comment, and 1 substance was added to the list for termination of review.

CIRS Group provides an overview of the acceptance and approval status of new food raw materials in China for the first half of 2024.

List of new food raw materials accepted in the first half of 2024 (16 types)

In the first half of 2024, China’s NHC accepted the applications for 16 new food raw materials. Among these, only four were imported, with the majority being domestically produced. The technical review status of each product is as follows:

S.N.	Date of acceptance	Acceptance No.	Name	Review status
1	January 2, 2024	卫食新申字(2024) No. 0001	Acer truncatum	Delivered an extension notice on February 6, 2024
2	January 2, 2024	卫食新进申字(2024) No. 0001	Comb extract	Delivered an extension notice on February 6, 2024
3	January 2, 2024	卫食新申字(2024) No. 0002	Gardenia oil	Delivered an extension notice on February 6, 2024
4	March 13, 2024	卫食新进申字(2024) No. 0002	Brewer’s yeast CNCM I-3799	Delivered an extension notice on April 2, 2024
5	January 5, 2024	卫食新申字(2024) No. 0003	Camellia chrysantha cell culture	Delivered an extension notice on February 6, 2024
6	March 18, 2024	卫食新进申字(2024) No. 0003	Lutein easter	Delivered an extension notice on April 2, 2024
7	March 14, 2024	卫食新申字(2024) No. 0004	Luohanshen	Delivered an extension notice on April 2, 2024
8	April 29, 2024	卫食新进申字(2024) No. 0004	Lemon Myrtle	Delivered an extension notice on May 30, 2024
9	March 21, 2024	卫食新申字(2024) No. 0005	Tender leaf seedlings of CARTHAMI FLOS	Delivered an extension notice on April 2, 2024
10	May 10, 2024	卫食新申字(2024) No. 0006	Pyrroloquinoline quinone disodium salt	Delivered an extension notice on May 30, 2024
11	May 15, 2024	卫食新申字(2024) No. 0007	Camelina sativa seed oil	Delivered an extension notice on May 30, 2024
12	May 17, 2024	卫食新申字(2024) No. 0008	Cis-15-Tetracosenoic Acid	Delivered an extension notice on June 4, 2024
13	May 17, 2024	卫食新申字(2024) No. 0009	L-Ergothioneine	Delivered an extension notice on May 30, 2024
14	May 20, 2024	卫食新申字(2024) No. 0010	Bacillus subtilis QK02	Delivered an extension notice on June 4, 2024
15	June 13, 2024	卫食新申字(2024) No. 0011	Luohanshen	Under review
16	June 20, 2024	卫食新申字(2024) No. 0012	Xiangyu peony	Under review

List of new food raw materials issued for public comment in the first half of 2024 (7 types)

In the first half of 2024, 7 new food raw materials have passed the technical review of CFSA and were issued for public comment. This includes a revision of the announcement regarding the approved new food raw material, rye pollen (No. 3 of 2023). Details are as follows:

Maritime pine bark extract (draft announcement)

Name	Maritime pine bark extract
Basic information	Source: Pinus pinaster Aiton
Brief introduction of the production process	Prepared through grinding, extraction, filtration, concentration, drying, and other processes using maritime pine bark extract as the raw material.
Recommended intake	≤ 150 mg/day
Other information	Scope of use and maximum levels: Milk and milk products (0.2 g/kg for modified milk and flavored fermented milk, milk powder and the formulated products are converted according to the mass of liquid after preparation); beverages (0.08 g/kg for liquid beverages, solid beverages are converted according to the mass of liquid after preparation); jelly (1.4 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 information on the unsuitable population and consumption limits; and Food safety indicators must comply with the relevant requirements (see the draft announcement).
Date of acceptance	Accepted on December 23, 2021. Acceptance No.: 卫食新进申字(2021) No. 0012. Acceptance name: Maritime pine bark extract (Product name: Bi Rong Jian®)
Date of public consultation	Passed the technical review and issued for public comment on March 1, 2024.

Bifidobacterium longum subsp. infantis M-63 (draft announcement)

Name	Bifidobacterium longum subsp. infantis M-63
Other information	Being included in the List of Strains that Can be Used in Food; Food safety indicators must comply with GB 31639-2023 National Food Safety Standard - Strain Preparation for Food Processing, with Cronobacter sp. absent/100 g.
Date of acceptance	Accepted on November 6, 2023. Acceptance No.: 卫食新进申字 (2023) No. 0004. Acceptance name: Bifidobacterium longum subsp. infantis M-63
Date of public consultation	Passed the technical review and issued for public comment on March 1, 2024.

N-acetylglucosamine (draft announcement)

Name	N-acetylglucosamine
Basic information	Structure: CAS number: 7512-17-6 Molecular formula: C8H15NO6 Molecular weight: 221.21
Brief introduction of the production process	Prepared through the fermentation of Corynebacterium glutamicum RDG-2110, followed by filtration, concentration, crystallization, centrifugation, alcohol washing, drying, and other processes using glucose, corn syrup powder, ammonium sulfate, potassium phosphate monobasic and magnesium sulfate as raw materials.
Recommended intake	≤500 mg/day
Other information	Scope of use and maximum levels: Milk and milk products (0.5 g/kg for modified milk and flavored fermented milk, milk powder and the formulated products are converted according to the mass of liquid after preparation); beverages (0.5 g/kg for liquid beverages, solid beverages are converted according to the mass of liquid after preparation); jelly (3 g/kg); candy (10 g/kg); cake (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 information on the unsuitable population and consumption limits; and The specifications and food safety indicators must comply with the relevant requirements (see the draft announcement).
Date of acceptance	Accepted on April 6, 2023. Acceptance No.: 卫食新申字(2023) No. 0005. Acceptance name: N-acetylglucosamine
Date of public consultation	Passed the technical review and issued for public comment on March 1, 2024.

Nannochloropsis oil (draft announcement)

Name	Nannochloropsis oil
Basic information	Source: Nannochloropsis gaditana
Brief introduction of the production process	Prepared through ethanol extraction, filtration, purification, concentration, and other processes using Nannochloropsis gaditana as the raw material.
Recommended intake	≤ 2 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 information on the unsuitable population and consumption limits; Food safety indicators must comply with the relevant requirements (see the draft announcement).
Date of acceptance	Accepted on September 4, 2023. Acceptance No.: 卫食新申字(2023) No. 0013. Acceptance name: Nannochloropsis oil
Date of public consultation	Passed the technical review and issued for public comment on April 28, 2024.

Rye pollen (draft announcement)

Name	Rye pollen
Other information	Rye pollen was approved as a new food raw material in Announcement No. 3 of 2023 by the NHC. Based on industry data and reviewed by the Expert Review Committee, it is now proposed to revise the dietary fiber content requirement in the announcement to be ≥30%.
Date of public consultation	Passed the technical review and issued for public comment on April 28, 2024.

Egg yolk phospholipid and protein (draft announcement)

Name	Egg yolk phospholipid and protein
Basic information	Source: Egg yolk powder
Brief introduction of the production process	Prepared through granulation, supercritical CO2 extraction, separation, and other processes using egg yolk powder as the raw material.
Recommended intake	≤ 5 g/day
Other information	The scope of use does not include infants and young children food. The labels and instructions shall indicate the consumption limits; The specifications and food safety indicators must comply with the relevant requirements (see the draft announcement).
Date of acceptance	Accepted on August 28, 2023. Acceptance No.: 卫食新申字(2023) No. 0011. Acceptance name: Egg yolk phospholipid
Date of public consultation	Passed the technical review and issued for public comment on April 28, 2024.

Stevia leaf polyphenols (draft announcement)

Name	Stevia leaf polyphenols
Basic information	Source: Stevia rebaudiana Bertoni
Brief introduction of the production process	Prepared through ethanol extraction, filtration, concentration, drying, and other processes by using stevia leaves as the raw material.
Recommended intake	≤500 mg/day (expressed as total polyphenols)
Other information	The scope of use does not include infants and young children food. The labels and instructions shall indicate the consumption limits; The specifications and food safety indicators must comply with the relevant requirements (see the draft announcement).
Date of acceptance	Accepted on September 7, 2023. Acceptance No.: 卫食新申字(2023) No. 0015. Acceptance name: Stevia extract
Date of public consultation	Passed the technical review and issued for public comment on June 14, 2024.

List of approved new food raw materials in the first half of 2024 (6 types)

Among the 6 new food raw materials approved in the first half of 2024 are 3 strains that can be used in food: Pichia kluyveri, Bacillus subtilis DE111, and Leuconostoc pseudomesenteroide. Notably, in terms of safety considerations, Bacillus subtilis DE111 is the first strain to be included in the List of Strains that Can Be Used in Food under its strain number. Detailed approval information for each product is as follows:

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	The labels and instructions shall bear a statement indicating that they should not be consumed by infants, pregnant women and lactating women, along with information on the unsuitable population and consumption limits; Food safety indicators must meet the requirements specified in the official announcement.
Date of acceptance	(1) Date of acceptance: unknown. Acceptance No.: 卫食新申字(2010) No. 0027. Acceptance name: Dendrobium officinale Kimura et Migo germ culture (2) Date of acceptance: unknown. Acceptance No.: 卫食新申字(2012) No. 0009. Acceptance name: Dendrobium huoshanense C. Z. Tang et S. J. Cheng protocorm (3) Accepted on October 10, 2019. Acceptance No.: 卫食新申字(2019) No. 0002. Acceptance name: Dendrobium officinale Kimura et Migo protocorm
Date of public consultation	Passed the technical review and issued for public comment on December 25, 2019.
Date of official approval	Officially approved on March 13, 2024, according to Announcement No. 2 of 2024.

Meso-zeaxanthin

Name	Meso-zeaxanthin
Basic information	Source: Tagetes erecta L. Structure: CAS number: 31272-50-1 Molecular formula: C₄₀H₅₆O₂ Molecular weight: 568.88
Brief introduction of the production process	Prepared through dehydration, grinding, extraction, isomerization, purification, and other processes using flowers of Tagetes erecta L. as the raw material.
Recommended intake	≤ 8 mg/day (expressed as Meso-zeaxanthin)
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 the provisions of GB 24405. 3) Food safety indicators must comply with the requirements specified in the official announcement.
Date of acceptance	Accepted on March 17, 2022. Acceptance No.: 卫食新申字(2022) No. 0002. Acceptance name: Meso-zeaxanthin
Date of public consultation	Passed the technical review and issued for public comment on August 28, 2023.
Date of official approval	Officially approved on March 13, 2024, according to Announcement No. 2 of 2024.

Pichia kluyveri

Name	Pichia kluyveri
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 fermented wine, fruit and vegetable juices, and tea drinks (excluding food for infants and young children). The labels and instructions must bear a statement of the scope of use. 2) Food safety indicators must comply with the requirements specified in GB 31639-2023 National Food Safety Standard - Strain Preparation for Food Processing.
Date of acceptance	Accepted on December 5, 2022. Acceptance No.: 卫食新进申字(2022) No. 0006. Acceptance name: Pichia kluyveri
Date of public consultation	Passed the technical review and issued for public comment on August 28, 2023.
Date of official approval	Officially approved on March 13, 2024, according to Announcement No. 2 of 2024.

Bacillus subtilis DE111

Name	Bacillus subtilis DE111
Other information	Being included in the List of Strains that Can Be Used in Food. The scope of use does not include infants and young children food. Food safety indicators must comply with the requirements specified in GB 31639-2023 National Food Safety Standard - Strain Preparation for Food Processing.
Date of acceptance	Accepted on March 9, 2023. Acceptance No.: 卫食新申字(2023) No. 0003. Acceptance name: Bacillus subtilis
Date of public consultation	Passed the technical review and issued for public comment on August 28, 2023.
Date of official approval	Officially approved on March 13, 2024, according to Announcement No. 2 of 2024.

L-alpha-Glycerylphosphorylcholine

Name	L-alpha-Glycerylphosphorylcholine
Basic information	Structure: CAS number: 28319-77-9 Molecular formula: C₈H₂₀NO₆P Molecular weight: 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 dry mass)
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 information on the unsuitable population and consumption limits. The specifications and food safety indicators must comply with the requirements specified in the official announcement.
Date of acceptance	Accepted on September 6, 2023. Acceptance No.: 卫食新申字(2023) No. 0014. Acceptance name: L-alpha-Glycerylphosphorylcholine
Date of public consultation	Passed the technical review and issued for public comment on December 22, 2023.
Date of official approval	Officially approved on March 13, 2024, according to Announcement No. 2 of 2024.

Leuconostoc pseudomesenteroides

Name	Leuconostoc pseudomesenteroides
Other information	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. Food safety indicators must comply with the requirements specified in GB 31639-2023 National Food Safety Standard - Strain Preparation for Food Processing.
Date of acceptance	Accepted on September 11, 2023. Acceptance No.: 卫食新进申字 (2023) No. 0002. Acceptance name: Leuconostoc pseudomesenteroides
Date of public consultation	Passed the technical review and issued for public comment on December 22, 2023.
Date of official approval	Officially approved on March 13, 2024, according to Announcement No. 2 of 2024.

Food raw materials included in the list for termination of review in the first half of 2024 (1 type)

In the first half of 2024, one food raw material, L-Theanine, was included in the termination of review list. The list now includes 74 products.

L-Theanine

Name

L-Theanine

Review opinion

Theanine was approved as a new food raw material in Announcement No. 15 of 2014 by the former National Health and Family Planning Commission (NHFPC). This product is substantially equivalent to the approved L-Theanine, suggesting termination of review. Food safety indicators should comply with HNC Announcement No. 4 of 2023, with solvent residue divinylbenzene ≤ 50 μg/kg.

Acceptance date and number

Accepted on September 4, 2023. Acceptance No.: 卫食新申字(2023) No. 0012.

Acceptance name: L-Theanine

Conclusion

Compared to the same period in 2023, the number of applications accepted in the first half of this year has seen a significant increase (16), nearly matching the total accepted for the entire year of 2023 (22). Furthermore, it can been seen from the application process of the six raw materials that the overall review time is decreasing, with two products having application cycles of approximately six months each. CIRS Group advises that enterprises intending to apply should focus on materials preparation, which not only shortens the review cycle but also helps enterprises save time and costs.

For updates on the acceptance, public consultation, and approval announcements regarding new food raw materials, you can use “ChinaFoodDB”, the comprehensive digital intelligent query platform for food raw materials and additives developed by CIRS. Click here to use it for free!

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(Note: There may be omissions and inaccuracies in the data. The data in this article is for reference only, please refer to the official information released by government departments. CIRS Group welcomes any corrections.)

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