Analysis on the Registration Application of China New Food Raw Material (Novel Food) in 2021 - Regulatory News - Food & Food Contact Materials

Updated on 20 Jan. 2022

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In 2021, the National Health Commission of the People's Republic of China (NHC) issued 3 announcements (No.9, 2020; No.5, 2021; No.9, 2021) for the approval of new food raw materials (novel food), with 8 substances approved.

Besides, the websites of NHC and China National Center for Food Safety Risk Assessment (CFSA) shows that a total of 27 new food raw materials applications were accepted, 6 of public comments on ingredients were issued, and 11 of ingredients review were terminated.

CIRS will take you to the detailed information about the acceptance and approval of new food raw material in China in 2021 as following:

1. List of new food raw material application acceptance in 2021 (27 types)

In 2021, NHC accepted the 27 applications of new food raw material, including 15 domestic products and 12 products. The technical review status of them are shown in the following table.

S/N	Acceptance Date	Acceptance Code	Name	The technical review status
1	25/01/2021	衛食新申字(2021)第0001號	Kanzan flower	P assed the technical review, and issued for public comments (17/08/2021)
2	29/01/2021	衛食新申字(2021)第0002號	Diacylglycerol Oil	Be included in the termination review list
3	03/02/2021	衛食新申字(2021)第0003號	Sodium Hyaluronate	Be included in the termination review list
4	08/03/2021	衛食新申字(2021)第0004號	Pyrroloquinoline quinone disodium(PQQ)salt	P assed the technical review, and issued for public comments (17/08/2021)
5	18/03/2021	衛食新申字(2021)第0005號	Ming Lao(brand) garlic oil	Be included in the termination review list
6	29/03/2021	衛食新申字(2021)第0006號	Seed kernel of Xanthoceras sorbifolium Bunge	Not yet issue for public comments
7	06/04/2021	衛食新申字(2021)第0007號	N-Acetylneuraminic acid(Sialic Acid)	Not yet issue for public comments
8	12/04/2021	衛食新進申字(2021)第0001號	Isomaltodextrin	Not yet issue for public comments
9	19/04/2021	衛食新進申字(2021)第0002號	Leuconostoc pseudomesenteroides	Not yet issued for public comments
10	18/05/2021	衛食新申字(2021)第0008號	Sugarcane Extract	P assed the technical review, and issued for public comments (01/11/2021)
11	18/05/2021	衛食新申字(2021)第0009號	Isodon lophanthoides (Buchanan-Hamilton ex D. Don) H. Hara	Be included in the termination review list
12	18/05/2021	衛食新進申字(2021)第0003號	Bifidobacterium longum BB536	P assed the technical review, and issued for public comments (01/11/2021)
13	19/07/2021	衛食新進申字(2021)第0004號	Corn fermentation product	Not yet issue for public comments
14	02/08/2021	衛食新申字(2021)第0010號	D-Psicose	Not yet issue for public comments
15	09/09/2021	衛食新進申字(2021)第0005號	Elderberry extract	Not yet issue for public comments
16	13/09/2021	衛食新申字(2021)第0011號	Chlamydomonas reinhardtii	P assed the technical review, and issued for public comments (08/12/2021)
17	17/09/2021	衛食新進申字(2021)第0006號	Eggshell membrane powder	Not yet issue for public comments
18	22/09/2021	衛食新進申字(2021)第0007號	Wheat polar lipids	Not yet issue for public comments
19	25/10/2021	衛食新進申字(2021)第0008號	Rye Grass pollen	Not yet issue for public comments
20	26/10/2021	衛食新申字(2021)第0012號	Blueberry extract(Vaccinium croymbosum ‘Lanmei 1’)	Not yet issue for public comments
21	27/10/2021	衛食新申字(2021)第0013號	Microcrystalline Compound Catechin	Not yet issue for public comments
22	15/11/2021	衛食新進申字(2021)第0009號	Imidazole Dipeptide powder from chicken	Not yet issue for public comments
23	22/11/2021	衛食新進申字(2021)第0010號	Olive fruit extract	Not yet issue for public comments
24	22/11/2021	衛食新進申字(2021)第0011號	Marigold extract	Not yet issue for public comments
25	23/11/2021	衛食新申字(2021)第0014號	Leuconostoc mesenteroides subsp. cremoris	Not yet issue for public comments
26	20/12/2021	衛食新申字(2021)第0015號	Coreopsis tinctoria Nutt	Not yet issue for public comments
27	23/12/2021	衛食新進申字(2021)第0012號	Maritime pine bark extract (Pycnogenol®)	Not yet issue for public comments

2. List of new food raw material for public comments released by CFSA in 2021 (6 types)

A total of 6 new food raw materials have passed the technical review by the Expert Review Committee and issued for public comments. However, none of them have been officially approved.

2.1 Lactobacillus acidophilus NCFM (Draft announcement)

Latin Name	Lactobacillus acidophilus NCFM
Other information	1. Approved as a strain that can be used in infant and young children food. 2. Food safety indexes are implemented in accordance with the relevant national regulations.
Issued date	18/02/2021 Public comments on new food raw material--- Lactobacillus acidophilus NCFM
Acceptance date	20/10/2020, 衛食新申字(2020)第0007號

Note: In 2011, Lactobacillus acidophilus NCFM has been included in the”The List of strains that can be used in infant and young children food” and limit its use only for children over 1 year old food, The purpose of this application is to expand the scope for infants under 1 year old.

2.2 Kanzan flower (Draft announcement)

Name	Kanzan flower
Basic information	Species: Cerasus serrulata ‘Sekiyama’ Edible parts: flower
Other information	1. The substance shall not be consumed by infants, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions. 2. Food safety indexes are implemented in accordance with the relevant national regulations of other vegetables products.
Issued date	17/08/2021 Public comments on new food raw material Kanzan flower and Pyrroloquinoline quinone disodium (PQQ) salt
Acceptance date	25/01/2021, 衛食新申字(2021)第0001號

2.3 Pyrroloquinoline quinone disodium (PQQ) salt (Draft announcement)

Name	Pyrroloquinoline quinone disodium（PQQ）salt
Basic information	Molecular formula:C14H4N2Na2O8 Molecular weight:374.17
Brief introduction of production process	Using 6-amino-5-methoxyindole-1H-2-carboxylic acid ethyl ester and dimethyl 2-oxoglutaconate as raw materials, after coupling reaction, formation of quinoline ring, oxidation reaction and hydrolysis reaction of ester and refining.
Recommended intake	≤20 mg/d
Other information	1. Application scope and maximum usage: beverages (40 mg/ kg, solid drinks are converted according to the volume of liquid after preparation). 2. The substance shall not be consumed by infants, young children, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions. 3. See the announcement for details of food safety indicators and test method.
Issued date	17/08/2021 Public comments on new food raw material Kanzan flower and Pyrroloquinoline quinone disodium (PQQ) salt
Acceptance date	08/03/2021, 衛食新申字(2021)第0004號

2.4 Sugarcane Extract (Draft announcement)

Name	Sugarcane Extract
Brief introduction of production process	Using sugarcane as raw material, through squeezing, filtering, sugar separation and other processes to obtain sugarcane molasses, and then water and ethanol are used as extraction solvents to prepare powdered sugarcane extract through processes such as filtration, vacuum concentration, ion exchange and spray drying; or to prepare liquid sugarcane extract through processes such as filtration and vacuum distillation.
recommended daily intake	≤1 g/d(Sugarcane extract powder), or≤10 g/d(Sugarcane extract liquid)
Other information	1. The substance shall not be consumed by infants, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions. 2.See the announcement for details of food safety indicators and quality requirement.
Issued date	01/11/2021 Public comments on new food raw material Sugarcane Extract and Bifidobacterium longum subsp. longum BB536
Acceptance date	18/05/2021, 衛食新申字(2021)第0008號

2.5 Bifidobacterium longum subsp. longum BB536(Draft announcement)

Latin Name	Bifidobacterium longum subsp. longum BB536
Other information	1. A strain that can be used in infant and young children food. 2. Food safety indicators should conform to relevant Chinese standards.
Issued date	01/11/2021 Public comments on new food raw material Sugarcane Extract and Bifidobacterium longum subsp. longum BB536
Acceptance date	18/05/2021, 衛食新進申字(2021)第0003號

2.6 Chlamydomonas reinhardtii (Draft announcement)

Latin Name	Chlamydomonas reinhardtii
Basic information	Family: Chlamydomonaceae, Genus:Chlamydomonas
Brief introduction of production process	It was prepared by Chlamydomonas reinhardtii algae species for breeding, fermenter heterotrophic expansion culture and spray-drying.
Other information	1. The scope of use does not include infant and young children food. 2. Food safety indicators are implemented in accordance with the relevant regulations of algae and algae products.
Issued date	08/12/2021 Public comments on new food raw material--- Chlamydomonas reinhardtii
Acceptance date	13/09/2021, 衛食新申字(2021)第0011號

3. List of approved new food raw material in 2021 (8 types)

There were 8 new food raw materials approved in 2021, the detailed approval information are as follows:

3.1 Isaria cicadae Miq. fruit body (artificial cultivation)

Name	Isaria cicadae Miq. fruit body (artificial cultivation)
Basic information	Source: Artificially grown cicada fruit bodies Species: Cordyceps, Corynespora
Brief introduction of production process	Inoculate the strain of Isaria cicadae Miq. on culture medium for artificial culture. Then, harvest fruit bodies and dry them.
Recommended intake	≤3 g/day (Measured on dry products)
Supplement information	1. Infants, young children, pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption. 2. Using safety standard of edible fungi as reference for contaminant limit, see the announcement for more details.
Issued date	25/11/2019, passed the technical review, and issued for public comments
Approved date	07/01/2021, officially approved by Announcement No.9 of 2020

3.2 Sodium Hyaluronate

Name	Sodium Hyaluronate
Basic information	Source: Streptococcus equi subsp.zooepidemicus Molecular formula:（C14H20NNaO11）n，n=200–10000 Molecular Weight: 8.02×104–4.01×106
Brief introduction of production process	Using glucose, yeast powder, peptone as the culture medium, fermented from Streptococus equi subsp.zooepidemicus.
Recommended intake	≤200 mg/day
Supplement information	1. Application scope and recommended intake are as follow: Milk and dairy product (0.2 g/kg), Beverages (Volume of liquid beverages≤50 mL, 2.0g/kg, Volume of liquid beverages: 51-500 mL, 0.20 g/kg, Solid beverages are converted according to the liquid volume after preparation), Alcohol (1.0 g/kg), Cocoa products, chocolate and its product (including imitations and chocolate substitutes) and candy (3.0 g/kg), Frozen drinks (2.0 g/kg). 2. Infants, young children, pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption. 3. See the announcement for details of food safety indicators.
Acceptance date	23/06/2020, 衛食新申字(2020)第0004號
Issued date	03/09/2020, passed the technical review, and issued for public comments
Approved date	07/01/2021, officially approved by Announcement No.9 of 2020
Note	Sodium hyaluronate’s application was accepted again in 2021(03/02/2021,衛食新申字(2021)第0003號) , but the review has been terminated. Please refer to Table 4 of this article for details.

3.3 Lactobacillus kefiranofaciens subsp. kefiranofaciens

Latin Name	Lactobacillus kefiranofaciens subsp. kefiranofaciens
Supplement information	1. Approved as the edible strain, infants and young children are not suitable for consumption. 2. Food safety indicators should comply with relevant Chinese standards.
Issued date	14/07/2020, passed the technical review, and issued for public comments
Approved date	07/01/2021, officially approved by Announcement No.9 of 2020

3.4 β-1,3-/α-1,3-glucan

Name	β-1,3-/α-1,3-glucan
Basic information	Source: sucrose Molecular formula: (C6H10O5) n, n≥615
Brief introduction of production process	Using sucrose as raw materials, and produced by Rhizobium pusense fermentation, alcohol precipitation, filtration, separation, drying, crushing and other processes.
Recommended intake	≤3 g/day
Supplement information	1. Infants, young children, pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption. 2.See the announcement for details of food safety indicators and test method.
Acceptance date	08/12/2016, 衛食新申字(2016)第0012號, acceptance name is β-1,3-glucan (Sola glue)
Issued date	22/05/2019, passed the technical review, and issued for public comments
Approved date	25/04/2021, officially approved by Announcement No.5 of 2021

3.5 Dihydroquercetin

Name	Dihydroquercetin
Basic information	Source: Pinaceae, Laricoideae, Larix, Sect. Larix, Larix olgensis. Part: root CAS: 480-18-2 Molecular formula: C15H12O7
Brief introduction of production process	Using the roots of artificially planted Larix olgensis as raw materials, and produced by the following operations: peeling, tearing, extraction, concentration, alcohol precipitation, supernatant concentration, extraction, re-concentration, crystallization, centrifugation and separation, freeze vacuum drying, crushing and sieving, etc.
Recommended intake	≤100 mg/day
Supplement information	1. Use scope and maximum usage: Drinks: 20 mg/L; Flavored fermented milk: 20 mg/kg; Cocoa product, chocolate and chocolate products: 70 mg/kg. 2. Infants, young children, children (≤14 years), pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption. 3. See the announcement for details of food safety indicators.
Issued date	12/11/2020, passed the technical review, and issued for public comments
Approved date	25/04/2021, officially approved by Announcement No.5 of 2021

3.6 Lactobacillus rhamnosus MP108

Latin Name	Lactobacillus rhamnosus MP108
Supplement information	1. The strain that can be used in infant and young children food. 2. Food safety indicators should comply with relevant Chinese standards.
Acceptance date	13/12/2019, 衛食新申字(2019)第0006號
Issued date	12/11/2020, passed the technical review, and issued for public comments
Approved date	25/04/2021, officially approved by Announcement No.5 of 2021

3.7 Nannochloropsis gaditana

Latin Name	Nannochloropsis gaditana
Brief introduction of production process	Produced by inoculation, cultivation, concentration, drying, etc.
Recommended intake	≤2 g/day (dry product)
Supplement information	1. Infants, young children, pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption. 2. Food safety indexes are implemented in accordance with the relevant national regulations of edible algae.
Approved date	25/04/2021, officially approved by Announcement No.5 of 2021

3.8 Rumexpatientia L. ×Rumextianshanicus A. Los

Latin Name	Rumexpatientia L. ×Rumextianshanicus A. Los
Basic information	Species: Polygonaceae Juss., Rumex acetosa L. Edible parts: Stem and leaves
Other information	1. The substance shall not be consumed by infants, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions. 2. Food safety indexes are implemented in accordance with the relevant national regulations of leaf vegetables.
Acceptance date	10/10/2019, 衛食新申字（2019）第0003號
Issued date	12/11/2020, passed the technical review, and issued for public comments
Approved date	22/10/2021, officially approved by Announcement No.9 of 2021

4. List of terminated reviewed products in 2021 (11 types)

A total of 11 new food ingredients were included in the termination review list in 2021( So far, there are 65 products in this list). For new food raw materials, getting the review results of the "substantially equivalent" and "local traditional eating habits" in the termination review is also a way of "getting approval." The review opinions are as follows in the table.

S/N	Product Name	Review Opinions	Acceptance Date and No
1	Eurotium cristatum(CGMCC NO.8730)	The application scope of this strain is tea, and it belongs to the category of "Strains that are traditionally used in food production and processing are allowed to continue to be used" in the The List of Strains That Can Be Used for Food, it is recommended to terminate the review.	29/11/2016,衛食新申字(2016)第0011號
2	Leaf of Strigose Hydrangea	This product has local traditional eating habits, and it is recommended to manage in accordance with Article 29 of the Food Safety Law.	15/08/2017,衛食新申字(2017)第0006號
3	Cardamine circaeoides Hook. f. et Thoms.	This product has a long history of human consumption in many provinces, it is recommended to terminate the review, and refers to the standard management of leaf vegetables: limits of contaminants in food should comply with the regulations of GB 2762, and maximum residue limits of pesticides in food should comply with the regulations of GB 2763.	10/12/2020,衛食新申字(2020)第0009號
4	Haematococcus pluvialis oil（Astaxanthin oil）	Haematococcus pluvialis has been approved as a new resource food. The astaxanthin in this product is basically the same as Haematococcus pluvialis, thus it is recommended to terminate the review. According to the total astaxanthin in Haematococcus pluvialis, the consumption of Haematococcus pluvialis oil is ≤240 mg/day.The total astaxanthin content of Haematococcus pluvialis oil is ≥5%, the ratio of the all-trans astaxanthin content to the total astaxanthin content is ≥70%, and the microcystin- LR, RR, YR should all be less than 1μg/kg. The scope of use does not include foods for infants and young children. The food safety indicators are implemented in accordance with the relevant regulations of vegetable oils.	Acceptance date is unknown, Acceptance No is”衛食新進申字(2019)第0001號”
5	Ming Lao（Brand） garlic oil	In view of the fact that garlic oil has been listed in the national food safety standard "Standard for Uses of Food Additives" (GB 2760), the main ingredient in this product is caprylic capric triglycerride (>98%) as an approved new food raw material, thus this it is not belongs to the category of new food raw material and it is recommended to terminate the review.	18/03/2021,衛食新申字(2021)第0005號
6	Trollius chinensis Bunge	In view of the fact that there are a variety of single prescriptions and prescription preparations of Trollius chinensis Bunge have been included in the "Pharmacopeia of the People's Republic of China", and it has clear pharmacological activity, thus it is recommended to terminate the review.	24/09/2020,衛食新申字(2020)第0006號
7	L-Arabinose	This product is made from gum arabic as raw material, and is prepared by dilute acid hydrolysis,neutralization, chromatographic separation, desalination, concentration, crystallization, drying and other processes. Substantially equivalent to L-arabinose that has been approved and announced(No.12, 2008). When used as a food raw material, it should be implemented in accordance with the relevant contents of the announced L-arabinose, and the food safety indicators are implemented in accordance with the relevant regulations of sugar.	21/12/2020,衛食新申字(2020)第0010號
8	Diacylglycerol oil	This product uses olive oil, linseed oil, camellia seed oil, soybean oil, rapeseed oil, peanut oil, corn oil and other edible vegetable oils as raw materials, lipase preparations, water, glycerin, etc. as main auxiliary materials, made by lipase catalysis, distillation separation, decolorization, deodorization and other processes. Substantially equivalent to diacylglycerol oil that has been approved and announced (N o.18, 2009). When used as a food raw material, it should be implemented in accordance with the relevant contents of the announced diacylglycerol oil, and the food safety indicators are implemented in accordance with the relevant regulations of vegetable oil.	29/01/2021,衛食新申字(2021)第0002號
9	Sodium Hyaluronate	This product uses glucose, yeast powder, peptone, etc. as the culture medium, and is produced by fermentation of Streptococcus equi subsp. zooepidemicus. Substantially equivalent to diacylglycerol oil that has been approved and announced (N o.9, 2020). it is recommended to terminate the review, and is implemented in accordance with the announced sodium hyaluronate.	03/02/2021,衛食新申字(2021)第0003號
10	Milk Minerals	Substantially equivalent to milk minerals that has been approved and announced(N o.18, 2009). This product’s quality index is implemented in accordance with product quality specifications, and the health and safety indicators are implemented in accordance with relevant standards.	/
11	Isodon lophanthoides (Buchanan-Hamilton ex D. Don) H. Hara	This product has been approved as a new food raw material for tea beverages, and the application is extended to tea substitute. Based on the provided edible history data and safety assessment data, it was agreed to expand. It is recommended to terminate the review, and the food safety indicators shall be implemented as follows: Lead (calculated as Pb)≤2mg/kg; total Arsenic (calculated as As)≤0.5mg/kg; BHC≤0.02mg/kg; DDT≤0.02mg/ kg.	18/05/2021,衛食新申字(2021)第0009號

Summary

In 2021, a total of 27 new applications were accepted by CFSA, which is more than twice of last year. Meanwhile, the approved products in this year has doubled from last year (a total of 4 products approved in 2020 and a total of 8 products approved in 2021).

As one of the “Three New Foods”, new food raw materials (novel food) have the most strict registration requirements. It usually takes 2 to 3 years from the application acceptance to the final approval. However, it can be found that among 6 substances issued for public comments in 2021, 5 of them were submitted in this year as well , which shows than when the applicant is well prepared, the registration timeline can be greatly shortened.

The new food raw material application timeline depends on its characteristics, usage history, research & development data, and safety assessment data. Enterprises should strengthen their understanding and implementation on regulations and policies, and fully prepared for the application of new food raw materials.

From 2008, NHC officially accepted about 400 applications of new food raw materials, 151 of them were approved, 65 of them were terminated to review. You can contact CIRS Group to obtain the “Guideline on New Food Raw Material Chinese Market Access” to view the complete list of approvals and termination of review.

If you have any needs or questions, please contact us at service@cirs-g roup .com.

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