Approval Status of New Food Raw Materials (Novel Food) in the First Half of 2023 - Regulatory News - Food & Food Contact Materials

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As of June 30th, the National Health Commission in China (NHC) issued two announcements (No.1 of 2023; No.3 of 2023), with a total of 42 products approved. Among them, 3 were new food raw materials (novel food), including, Leuconostoc mesenteroides subsp. Cremoris, Blueberry anthocyanins and Rye pollen.

CIRS will introduce the detailed information about the acceptance and approval of new food raw materials in China in the first half of 2023 as following:

List of new food raw materials accepted in the first half of 2023 (6 types)

In the first half of 2023, NHC accepted 6 new food raw materials, all of which are domestic products. The technical review status is as following:

No.	Acceptance Date	Acceptance Code	Acceptance Name	Technical Review Status
1	2023.02.02	衛食新申字(2023) 第0001號	Pyrroloquinoline quinone disodium\ (PQQ) salt	2023.04.23 Issued for public comments
2	2023.02.15	衛食新申字(2023)第0002號	Pleurotus eryngii mycelium	2023.06.20 Rejected
3	2023.03.09	衛食新申字(2023)第0003號	Bacillus subtilis	Not issued for public comments yet
4	2023.03.24	衛食新申字(2023)第0004號	Fermented mycelial proteins of Fusarium venenatum strain TB01	2023.06.20 Rejected
5	2023.04.06	衛食新申字(2023)第0005號	N-Acetylglucosamine	Not issued for public comments yet
6	2023.05.10	衛食新申字(2023)第0006號	Pyrroloquinoline quinone disodium (PQQ) salt	Not issued for public comments yet

List of new food raw materials released for public comments in the first half of 2023 (12 types)

In the first half of 2023, 12 new food raw materials (novel food) have passed the technical review of CFSA and were issued for public comments. Among them, Blueberry anthocyanins and Rye pollen have been officially approved.

The remaining 10 raw materials for public comments are as follows:

Green Tea Catechins (Draft announcement)

Name	Green Tea Catechins
Basic information	Source: Camelliasinensis (L.) O. Ktze.
Brief introduction of the production process	Prepared through alcohol extraction, concentration, separation, extraction, enzymolysis, concentration drying and other processes by using Camelliasinensis (L.) O. Ktze. as raw materials.
Recommended intake	≤300 mg/d
Other information	Application scope and maximum usage level: beverages (0.6 g/kg, solid beverages are converted according to the mass of liquid after preparation), candy (0.2g/kg).
Issued date	Passed the technical review and issued for public comments on January 12, 2023

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 eggshells as raw materials.
Recommended intake	≤500 mg/d
Issued date	Passed the technical review and issued for public comments on January 12, 2023

Yellowhorn seed kernel (Draft announcement)

Name	Yellowhorn seed kernel
Basic information	Source: Seed of Xanthoceras sorbifolium Bunge
Brief introduction of the production process	Prepared through drying, magnetic separation, shelling, screening and other processes by using seed of Xanthoceras sorbifolium Bunge as raw materials.
Recommended intake	≤20g/d
Issued date	Passed the technical review and issued for public comments on March 10, 2023

Yellowhorn leaf (Draft announcement)

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 young leaves of Xanthoceras sorbifolium Bunge as raw materials.
Recommended intake	≤6g/d
Other information	Edible method: brewing
Issued date	Passed the technical review and issued for public comments on March 10, 2023

Yeast protein (Draft announcement)

Name	Yeast protein
Main component	Yeast protein
Brief introduction of the production process	Using Saccharomyces Cerevisiae as the strain basis with adding carbon source, nitrogen source, and other nutrients for fermentation, through breeding, fermenting, and centrifuging to get the raw material; prepared through removing nucleic acid, centrifuging, enzymolysis, extraction, purification, separation, sterilization, drying, and other processes.
Issued date	Passed the technical review and issued for public comments on March 10, 2023

Peach gum (Draft announcement)

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	≤30g/d
Issued date	Passed the technical review and issued for public comments on April 23, 2023

Tiger nut (Draft announcement)

Name

Tiger nut

Basic information

Source: Cyperus esculentus L. var. sativus Boeck.

Edible part: stem tubers

Issued date

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

Leuconostoc mesenteroides subsp. Cremoris (Draft announcement)

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

Pyrroloquinoline quinone disodium (PQQ) salt (Draft announcement)

Name	Pyrroloquinoline quinone disodium (PQQ) salt
Brief introduction of the production process	Preparing through fermentation, extraction, purification, crystallization, drying, and other processes by using the Methylovorus glucosotrophus as a production strain.
Recommended intake	≤20mg/d
Other information	Application scope and maximum usage level: beverages (40 mg/kg，solid beverages are converted according to the mass of liquid after preparation)
Issued date	Passed the technical review and issued for public comments on April 23, 2023

Yerba mate (Draft announcement)

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 by using leaves of Ilex paraguariensis A.St.-Hil. as raw materials.
Other information	Edible method: brewing
Issued date	Passed the technical review and issued for public comments on June 21, 2023

List of new food raw materials approved in the first half of 2023 (3 types)

There were 3 new food raw materials approved in the first half of 2023, including 1 strain that can be used in food: Leuconostoc pseudomesenteroides. The detailed information is as follows:

Leuconostoc pseudomesenteroides

Name	Leuconostoc pseudomesenteroides
Other information	Being included in the List of Strains that Can be Used in Food, and approved for fermented milk, flavored fermented milk, cheese, fermentation milk drinks and lactobacillus drinks (non-solid drinks), excluding infants and young children food.
Acceptance date	Accepted on April 19, 2021. The acceptance code is 衛食新進申字(2021)第0002號. Acceptance name: 假腸膜明串珠菌 (Leuconostoc pseudomesenteroides)
Issued date	Passed the technical review and issued for public comments on June 29, 2023
Approved date	Officially approved on March 2, 2023 according to Notice No.1, 2023

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 blueberry as raw materials.
Recommended intake	≤800 mg/d
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).
Acceptance date	Accepted on October 26, 2021. The acceptance code is衛食新申字(2021)第0012號. Acceptance name: 藍美1號藍莓提取物 (Lanmei No. 1 Blueberry extracts)
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

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 using rye as raw materials.
Recommended intake	≤1.5g/d
Acceptance date	Accepted on October 25, 2021. The acceptance code is衛食新進申字(2021)第0008號.
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

Raw materials included in the Review Termination List (2 types)

In the first half of 2023, 2 raw materials were included in the review termination list, and currently there are 70 products on the list.

Fructo-oligosaccharides (from brown sugar)

Name

Fructo-oligosaccharides (from brown sugar)

Review opinions

Fructo-oligosaccharides (from brown sugar) is made from sucrose derived from brown sugar and catalyzed by fructosyltransferase permitted by GB2760. There are national standards for Fructo-oligosaccharides. When used as a food raw material, the color of the substance is reddish brown, the content of Fructo-oligosaccharides (on a dry basis) is ≥ 45g/100g, the ash content is ≤ 3.0g/100g, and there are no regulations for chromaticity and transmittance. Other indicators shall be be consistent with the national standards for Fructo-oligosaccharides (GB/T23528).

Chicken concentrated powder

Name

Chicken concentrated powder

Review opinions

Chicken concentrated powder is made from chicken through boiling, filtering, concentrating, drying and other processes, and does not fall into the scope of new food raw materials. It is recommended to terminate the review, follow the management measures of common food, and follow the food safety indicators in accordance with the provisions regarding condiments of the currently valid national food safety standards in China.

Raw materials rejected in the first half of 2023 (3 types)

In the first half of 2023, 3 products were rejected for approval by NHC including 2 microorganism fermented protein products accepted in 2023 and Periploca sepium Bunge leaves accepted in 2022.

No.

Acceptance date

Acceptance code

Name

Review process/conclusion

2022.08.11

衛食新申字(2022)第0009號

Periploca sepium Bunge leaves

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

2023.02.07 Issuance of a decision not to grant administrative permission

2023.02.15

衛食新申字(2023)第0002號

Pleurotus eryngii mycelium

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

2023.06.20 Issuance of a decision not to grant administrative permission

2023.03.24

衛食新申字(2023)第0004號

Fermented mycelial proteins of Fusarium venenatum strain TB01

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

2023.06.20 Issuance of a decision not to grant administrative permission

Conclusion

When applying for the registration of new food raw materials, the most time-consuming stage, also to which enterprises pay most attention is often the period before public comments.

The acceptance and comments seeking period are the most time-consuming in the whole registration process. It also attracts the most attentions from enterprises. However, in merely the first half of 2023, CFSA officially released 4 notices seeking public comments on the approval of new food raw materials, with 12 products passing technical reviews, four times as many as that in 2022 (Throughout 2022, only 3 notices were released with 3 raw materials involved). In terms of the registration period, most of the applications will be released for public comments within 1 year. One reason is that related enterprises have raised their awareness of the requirements for new food raw materials application, another reason is that competent authorities have quickened their pace by shortening the review cycle.

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

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