Analysis on the Registration Application of New Food Raw Material (Novel Food) in 2020 - Regulatory News - Food & Food Contact Materials

In 2020, the National Health Commission of the People's Republic of China (NHC) issued only one announcement (No.4, 2020) for the approval of new food raw materials. It includes three strains that can be used in infant and young children food: Lactobacillus helveticus R0052, Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and one plant-derived raw material Penthorum chinense Pursh.

Besides, the websites of NHC and China National Center for Food Safety Risk Assessment (CFSA) shows that a total of 11 new food raw material applications were accepted, 7 of public comments on ingredients were issued, and 7 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 2020 as following:

1. List of new food raw material application acceptance in 2020 (11 types)

In 2020, NHC accepts the 11 applications of new food raw material, including 10 domestic raw materials and 1 imported raw material. Among them, the application of Xanthoceras oil that was accepted on 10th March has been terminated, and managed it as a general food. Sodium hyaluronate has passed the technical review on 3rd September and has issued for public comments. The other 9 applications were speculated under technical review or in process of providing supplement documents.

S.N.	Acceptance Date	Acceptance Code	Name of the New Food Raw Material
1	15/01/2020	衛食新申字(2020)第0001號	Tongkat Ali Extract
2	10/03/2020	衛食新申字(2020)第0002號	Xanthoceras oil
3	15/06/2020	衛食新申字(2020)第0003號	Calcium beta-hydroxy-beta-methylbutyrate
4	23/06/2020	衛食新申字(2020)第0004號	Sodium hyaluronate
5	01/09/2020	衛食新申字(2020)第0005號	Collagen Peptides (yak)
6	24/09/2020	衛食新申字(2020)第0006號	Chinese Globeflower Flower
7	20/10/2020	衛食新申字(2020)第0007號	Lactobacillus acidophilus NCFM
8	18/11/2020	衛食新申字(2020)第0008號	D-Psicose
9	18/11/2020	衛食新進申字(2020)第0001號	γ－aminobutyric acid
10	10/12/2020	衛食新申字(2020)第0009號	Cardamine circaeoides Hook. f. et Thoms.
11	21/12/2020	衛食新申字(2020)第0010號	L-Arabinose

2. List of new food raw material for public comments released by CFSA in 2020 (7 types)

A total of 7 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 Milk minerals. (Draft announcement)

Name	Milk minerals
Basic Information	Source: whey
Production process	Using whey as raw material, and made by purification, ultrafiltration and drying processes.
Recommend daily intake	≤5 g/day
Quality requirements	Appearance	White powder
	Calcium	23.0-28.0%
	Phosphorus	10.0-16.0%
	Protein	≤ 7.0%
	Fat	≤ 1.0%
	Lactose	4.0-11.0%
	Ash	70.0-78.0%
	Moisture	≤ 6.0%
	pH (10% Solution)	6.4-7.5
Supplement information	1. Infants and young children are not suitable for consumption. 2. Using the current China GB of dairy products as reference for safety index.
Issue Date/Link	14/07/2020 Public comments on new food raw material milk minerals and Lactobacillus kefiranofaciens subsp.kefiranofaciens
Acceptance date	06/02/2013, 衛食新進申字(2013)第0003號
Note	Milk mineral was approved as new resource food in 2009, while the production process and quality requirements of milk mineral for this time are different from the original announcement.

2.2 Lactobacillus kefiranofaciens subsp. kefiranofaciens (Draft announcement)

Name	Lactobacillus kefiranofaciens subsp. kefiranofaciens
Supplement information	1. Infants and young children are not suitable for consumption. The labels and instructions should indicate the unsuitable crowds. 2. Food safety indicators should comply with relevant Chinese standards.
Issued Date/Link	14/07/2020 Public comments on new food raw material milk minerals and Lactobacillus kefiranofaciens subsp.kefiranofaciens

2.3 Sodium Hyaluronate (Draft announcement)

Name	Sodium Hyaluronate
Basic information	Source: Streptococus equi subsp.zooepidemicus Structure: Molecular formula: (C14H20NNaO11)n, n: 200-10000 Molecular Weight: 8.02×104 —4.01×106
Production process	Using glucose, yeast powder, peptone as the culture medium, fermented from Streptococus equi subsp.zooepidemicus.
Recommended intake	≤200 mg/day
Quality requirement	Appearance	White granule or powder
	Sodium hyaluronate content	≥87.0%
	Moisture	≤10.0%
	PH	6.0-8.0
	Ash	≤13.0%
Other information	1. Application scope include: Milk and dairy product, Beverages, Alcohol, Cocoa products, chocolate and its product (including imitations and chocolate substitutes), candy, Frozen drinks, but not include infant and young children food. 2. Food safety indicators must meet the following requirements: Pb/(mg/kg): ≤0.5 As/(mg/kg): ≤0.3
Issued Date/Link	03/09/2020 Public comments on new food raw material---Sodium Hyaluronate
Acceptance date	Sodium hyaluronate has been accepted three times: 30/09/2013, 衛食新進申字(2013)第0030號, 29/09/2013, 衛食新申字(2013)第0034號, 23/06/2020, 衛食新申字(2020)第0004號
Note	Sodium hyaluronate was approved as new resource food in 2008, and the scope of use is health food raw material, this draft announcement expands its scope to general food.

2.4 Rumex patientia L. ×Rumex tianshanicus A. Los (Draft announcement)

Name	Rumex patientia L. ×Rumex tianshanicus A. Los
Basic information	Species: Polygonaceae Juss., Rumex acetosa L. Edible parts: stem and leaves
Recommended intake	≤50 g/day (Measured by fresh 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. 2. Food safety indexes are implemented in accordance with the relevant national regulations of leaf vegetables.
Issued Date/Link	12/11/2020 Public comments on 3 new food raw material
Acceptance date	10/10/2019, 衛食新申字(2019)第0003號

2.5 Dihydroquercetin (Draft announcement)

Name	Dihydroquercetin
Basic information	Source: Pinaceae, Laricoideae Melchior et Werd., Larix, roots of Larix olgensis Chemical name: 3,5,7,3',4'-Pentahydroxyflavanone CAS: 480-18-2 Molecular formula: C15H12O7 Structure:
Production process	Using the roots of artificial planted Larix olgensis as raw materials, made through processes of peeling, tearing, extraction, concentration, ethanol precipitation, supernatant concentration, extraction, re-concentration, crystallization, centrifugal separation, freeze vacuum drying, comminution, and sieving.
Recommended intake	≤100 mg/day
Quality requirement	Appearance	Light yellow or off-white powder
	Dihydroquercetin content	≥90.0%
Supplement information	1. Application scope and maximum usage: beverages (20 mg/L), fermented milk and flavored fermented milk (20 mg/kg), cocoa products, chocolate and chocolate products (70 mg/kg). 2. The substance shall not be consumed by infants, young children (under 14 years old), pregnant women and lactating women. Inapplicable population should be marked on labels and instructions. 3. Food safety indicators must meet the following requirements: Pb/ (mg/kg): ≤0.5 As/ (mg/kg): ≤0.3 Cd/ (mg/kg): ≤0.5 Hg/ (mg/kg): ≤0.1 Total plate count / (CFU/g): ≤1000 Coliform bacteria (MPN/g): ≤3.0 Mold &Yeast / (CFU/g): ≤50 Pathogenic bacteria (Salmonella, Staphylococcus): 0/25g
Issue Date/Link	12/11/2020 Public comments on 3 new food raw material

2.6 Lactobacillus rhamnosus MP108 (Draft announcement)

Name	Lactobacillus rhamnosus MP108
Supplement information	1. Strains that can be used in infant food. 2. Food safety indicators should comply with the relevant Chinese standards.
Issued Date/Link	12/11/2020 Public comments on 3 new food raw material
Acceptance date	13/12/2019, 衛食新申字(2019)第0006號

2.7 Haematococcus pluvialis oil (Draft announcement)

Name	Haematococcus pluvialis oil
Information	Source: Chlorophyta, Volvocales, Haematococcus Pluvialis
Production process	Select and breed excellent Haematococcus pluvialis algae species for artificial cultivation, harvest the Haematococcus pluvialis spores, made it through cell disruption and extraction.
Recommended intake	≤240 mg/day
Quality requirements	Appearance	Crimson oily liquid
	Total astaxanthin content	≥5%
	All-trans-Astaxanthin content/ Total astaxanthin content	≥70%
Supplement 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 vegetable oil. In addition, the content of microsystin (LR, RR, YR) ＜ 1 μg/kg
Issued Date/Link	28/12/2020 Public comments on new food raw material--- Haematococcus pluvialis oil

3. List of approved new food raw material in 2020 (4 types)

There were 4 new food raw materials approved in 2020, the detailed approval information are as follows:

3.1 Lactobacillus helveticus R0052

Name	Lactobacillus helveticus R0052
Supplement 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 relevant national regulations.
Acceptance date	30/09/2013, 衛食新進申字(2013)第0030號
Issued date	22/05/2019, passed the technical review, and issued for public comments
Approved date	02/06/2020, officially approved by Announcement No.4 of 2020

3.2 Bifidobacterium infantis R0033

Name	Bifidobacterium infantis R0033
Supplement 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.
Acceptance date	30/09/2013, 衛食新進申字(2013)第0032號
Issued date	22/05/2019, passed the technical review, and issued for public comments
Approved date	02/06/2020, officially approved by Announcement No.4 of 2020

3.3 Bifidobacterium bifidum R0071

Name	Bifidobacterium bifidum R0071
Supplement 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.
Acceptance date	30/09/2013, 衛食新進申字(2013)第0031號
Issued date	22/05/2019, passed the technical review, and issued for public comments
Approved date	02/06/2020, officially approved by Announcement No.4 of 2020

3.4 Penthorum?chinense Pursh.

Name	Penthorum?chinense Pursh.
Basic information	Species: Saxifragaceae Juss., Penthorum Edible parts: stem and leaves
Production process	Select artificially planted stems and leaves, made it through cleansing, moistening, cutting and drying.
Recommended intake	≤ 8 g/day
Supplement information	1. The substance shall not be consumed by infants, children, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions. 2. Edible methods: brew 3. Food safety indexes are implemented in accordance with relevant national regulations of tea.
Issued date	14/01/2019, passed the technical review, and issued for public comments
Approved date	02/06/2020, officially approved by Announcement No.4 of 2020

4. List of terminated reviewed products in 2020 (7 types)

A total of 7 new food ingredients were included in the termination review list in 2020. 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	Takifugu fasciatus	As the former General Office of the Ministry of Agriculture and the General Office of former China Food and Drug Administration issued the “Notice on Liberalizing the Processing and Operation of Breeding Takifugu rubripes and Takifugu fasciatus”, and the Ministry of Agriculture and Rural Affairs has announced the source base, it is recommended to terminate the review.	01/06/2011, 衛食新申字(2011) 0001號
2	Takifugu rubripes	As the former General Office of the Ministry of Agriculture and the General Office of former China Food and Drug Administration issued the “Notice on Liberalizing the Processing and Operation of Breeding Takifugu rubripes and Takifugu fasciatus”, and the Ministry of Agriculture and Rural Affairs has announced the source base, it is recommended to terminate the review.	2010.12.14, 衛食新申字(2010)第0028號 2010.08.06, 衛食新申字(2010)第0015號
3	Angelica sinensis	As the National Health Commission has issued the “Announcement of the six substances which are both food and Chinese medicines”, it is recommended to terminate the review.	2012.04.01, 衛食新申字(2012)第0007號
4	Cistanche deserticola	As the National Health Commission has issued the “Notice of management of nine substances which are both food and Chinese medicines”, it is recommended to terminate the review.	2015.07.06, 衛食新申字(2015)第0005號
5	Dendrobium officinale Kimura et Migo	As the National Health Commission has issued the “Notice of management of nine substances which are both food and Chinese medicines”, it is recommended to terminate the review.	2013.09.30, 衛食新申字(2013)第0039號
6	Idesia polycarpa oil	This product has a long history of human consumption, and the National Food and Strategic Reserves Administration has issued the standard "LS/T3258-2018 Idesia polycarpa oil ", thus it is recommended to terminate the review and manage it as general food.	2019.12.09, 衛食新申字(2019)第0005號
7	Xanthoceras oil	This product has a long history of human consumption, and the National Food and Strategic Reserves Administration has issued the standard "LS/T3265-2019 Xanthoceras Oil", thus it is recommended to terminate the review and manage it as general food.	2020.03.10，衛食新申字(2020)第0002號

Summary:

As one of the “Three New Foods” (including new food raw materials, new food additives and new food contact materials), new food raw materials (novel food) have the most complex and strict registration requirements and official audits. It usually takes at least 2 to 3 years from the acceptance to the approval, and the period from the acceptance to the issue for public comments is at least about 1 year.

The new food raw material application timeline depends on its characteristics, usage history, research and 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.

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

Note: From 2008, NHC officially accepted 370 applications of new food raw materials. 144 of them were approved, 54 of them were terminated to review. A complete list of approvals and termination of review is shown in the “Access Guide of New Food Raw Materials in China” from CIRS Group.

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