Analysis on the Registration Application of New Food Raw Material (Novel Food) in 2020

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

卫食新申字(2020)第0001号

Tongkat Ali Extract

2

10/03/2020

卫食新申字(2020)第0002号

Xanthoceras oil

3

15/06/2020

卫食新申字(2020)第0003号

Calcium beta-hydroxy-beta-methylbutyrate

4

23/06/2020

卫食新申字(2020)第0004号

Sodium hyaluronate

5

01/09/2020

卫食新申字(2020)第0005号

Collagen Peptides (yak)

6

24/09/2020

卫食新申字(2020)第0006号

Chinese Globeflower Flower

7

20/10/2020

卫食新申字(2020)第0007号

Lactobacillus acidophilus NCFM

8

18/11/2020

卫食新申字(2020)第0008号

D-Psicose

9

18/11/2020

卫食新进申字(2020)第0001号

γ-aminobutyric acid

10

10/12/2020

卫食新申字(2020)第0009号

Cardamine circaeoides Hook. f. et Thoms.

11

21/12/2020

卫食新申字(2020)第0010号

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, 卫食新进申字(2013)第0003号

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, 卫食新进申字(2013)第0030号,

29/09/2013, 卫食新申字(2013)第0034号,

23/06/2020, 卫食新申字(2020)第0004号

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, 卫食新申字(2019)第0003号

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, 卫食新申字(2019)第0006号

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, 卫食新进申字(2013)第0030号

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, 卫食新进申字(2013)第0032号

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, 卫食新进申字(2013)第0031号

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, 卫食新申字(2011) 0001号

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, 卫食新申字(2010)第0028号

2010.08.06, 卫食新申字(2010)第0015号

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, 卫食新申字(2012)第0007号

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, 卫食新申字(2015)第0005号

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, 卫食新申字(2013)第0039号

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, 卫食新申字(2019)第0005号

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,卫食新申字(2020)第0002号

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.

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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 Chinafrom CIRS Group.