Analysis of the Registration Application of New Food Raw Material (Novel Food) in 2019

In 2019, the National Health Commission of the People's Republic of China (NHC) issued only one announcement (No.2, 2019) for the approval of new food raw materials. There were three new raw materials approved, they are Lactobacillus curvatus, Ashitaba stem and leaf, and Loquat flower.

Besides, from websites of NHC and China National Center for Food Safety Risk Assessment (CFSA), a total of 6 new food raw material applications were accepted, 7 of public comments on ingredients were issued, and 2 of ingredients review were terminated. 

CIRS Group will take you to detailed information about the acceptance and approval of new food raw material in China in 2019.

1. List of new food raw material application acceptance in 2019 (6 types)

In 2019, NHC officially accepts the 6 applications of new food raw material. Among them, the application of Dendrobium Officinale Protocorm that was accepted on 12th June has passed the technical review on 25th November and has issued for public comments. The other 5 applications were speculated under technical review or providing supplement documents.  

S.N.

Acceptance Date

Acceptance Code

Name of the New Food Raw Material

1

05/05/2019

卫食新申字(2019)第0001号

Xylan

2

12/06/2019

卫食新申字(2019)第0002号

Dendrobium Officinale Protocorm

3

10/10/2019

卫食新申字(2019)第0003号

Rumex dapibus herba by.

4

09/12/2019

卫食新申字(2019)第0004号

Lactobacillus kefiranofaciens ZW3

5

09/12/2019

卫食新申字(2019)第0005号

Idesia polycarpa oil

6

13/12/2019

卫食新申字(2019)第0006号

Lactobacillus rhamnosus MP108

2. List of new food raw material for public comments released by CFSA in 2019 (7 types)

There were a total of 7 new food raw materials passed the technical review by the Expert Review Committee and issued for public comments. However, none of them have been officially approved.

2.1 Penthorum chinense Pursh. (Draft announcement)

Name

Penthorum chinense Pursh.

Information

Family: Saxifragales

Genus: Penthorum

Edible parts: Stems and leaves

Production process

Select, clean, wet, cut, and dry the stems and leaves of artificially planted Oriental penthorum.

Recommend daily intake

≤8 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. Consumption instruction: soak.

3. Using the current China GB of tea or substitute tea as reference for safety index.

Issued Date/Link

14/01/2019

Public comments on new food raw material---Penthorum chinense Pursh.

2.2 β-1,3-glucan (Draft announcement)

Name

β-1,3-glucan

Information

Resource:sucrose

Structural formula

Molecular formula:(C6H10O5)n,n≥615

Production process

Use sucrose as the raw material, and then made by fermentation (Rhizobium pusense), alcohol precipitation, filtration, separation, drying, crushing.

Recommended daily intake

≤3 g/day

Quality requirements

Character

White to light yellow powder

β-1,3-glucan(g/100g)

≥90

Moisture(g/100g)

≤4

Ash(g/100g)

≤5

Protein(g/100g)

≤3

Supplement information

1. Infants, pregnant women and lactating women are not suitable for consumption. The labels and instructions should indicate the unsuitable groups.

2. Using GB 28304 as reference for safety index.

Issued Date/Link

22/05/2019

Public comments on new food raw material---β-1,3-glucan, Lactobacillus helveticus R0052 and other new ingredients.

Acceptance date

08/12/2016, 卫食新申字(2016)第0012号

2.3 Lactobacillus helveticus R0052 (Draft announcement)

Name

Lactobacillus helveticus R0052

Supplement information

Approved as a strain that can be used in infant food.

Issued Date/Link

22/05/2019

Public comments on new food raw material---β-1,3-glucan, Lactobacillus helveticus R0052 and other new ingredients.

Acceptance date

30/09/2013,卫食新进申字(2013)第0030号

2.4 Bifidobacterium infantis R0033 (Draft announcement)

Name

Bifidobacterium infantis R0033

Supplement information

Approved as a strain that can be used in infant food.

Issued Date/Link

22/05/2019

Public comments on new food raw material---β-1,3-glucan, Lactobacillus helveticus R0052 and other new ingredients.

Acceptance date

30/09/2013,卫食新进申字(2013)第0032号

2.5 Bifidobacterium bifidum R0071 (Draft announcement)

Name

Bifidobacterium bifidum R0071

Supplement information

Approved as a strain that can be used in infant food.

Issued Date/Link

22/05/2019

Public comments on new food raw material---β-1,3-glucan, Lactobacillus helveticus R0052 and other new ingredients.

Acceptance date

30/09/2013,卫食新进申字(2013)第0031号

2.6 Dendrobium Officinale Protocorm (Draft announcement)

Name

Dendrobium Officinale Protocorm

Information

Source: Orchidaceae, Dendrobium, Dendrobium Officinale (Dendrobium officinale Kimura et Migo).

Production process

The stem of Dendrobium candidum is obtained through tissue culture to get the original bulb or bush buds, then made by collecting and drying.

Recommended daily intake

Dry product≤3.5 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. Using the current China GB of stem vegetables as reference for safety index.

Issued Date/Link

25/11/2019

Public comments on new food raw material--- Dendrobium Officinale Protocorm and Isaria cicadae Miq. fruit body (artificial cultivation).

Acceptance date

12/06/2019, 卫食新申字(2019)第0002号

2.7 Isaria cicadae Miq. fruit body (artificial cultivation) (Draft announcement)

Name

Isaria cicadae Miq. fruit body (artificial cultivation)

Information

Source: Artificially grown cicada fruit bodies

Species: Cordyceps, Corynespora

Production process

Inoculate the cicada flower on the culture medium for artificial culture. Then, harvest fruit bodies and dry them.

Recommended daily intake

Dry product≤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. Using safety standard of edible fungi as reference for contaminant limit. Mycotoxins Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2, Deoxynivalenol, Ochratoxin A, Zearalenone, and Beauverin cannot be detected.

Issued Date/Link

25/11/2019

Public comments on new food raw material--- Dendrobium Officinale Protocorm and Isaria cicadae Miq. fruit body (artificial cultivation).

3. List of approved new food raw material in 2019 (3 types)

There were 3 new food raw materials approved in 2019. According to the acceptance date, the timeline of the 3 applications is about 2 to 3 years.

3.1 Lactobacillus curvatus

Name

Lactobacillus curvatus

Supplement information

1. Scope of application: fermented meat products, fermented milk and dairy products (excluding infant food).

2. Infants and young children are not suitable for consumption. The labels and instructions should indicate unsuitable groups.

3. Food safety indicators should meet relevant Chinese standards.

Acceptance date

21/12/2015, 卫食新进申字(2015)第0009号

Issued date

28/11/2017, passed the technical review, and issued for public comments

Approved date

29/05/2019, officially approved by Announcement No.2 of 2019

3.2 Ashitaba stem and leaf

Name

Ashitaba stem and leaf

Information

Family: Apiaceae

Genus: Angelica keiskei

Edible parts: stems and leaves

Recommend daily intake

Fresh product≤50 g/day (Recommended consumption of dry products is calculated based on 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 and the limit of consumption.

2. Using safety standard of vegetables as reference for safety index.

Acceptance date

28/10/2016,卫食新申字(2016)第0010号

Issued date

07/08/2018, passed the technical review, and issued for public comments

Approved date

29/05/2019, officially approved by Announcement No.2 of 2019

3.3 Loquat flower

Name

Loquat flower

Information

Family: Rosaceae

Genus: Eriobotrya japonica (Thunb.) Lindl.

Edible parts: flowers

Production process

Using Loquat flower as raw materials, through stem removal, cleaning and drying to make the product.

Recommended daily intake

Dry product≤8 g/day

Supplement information

1. Infants, pregnant women and lactating women are not suitable for consumption, and the labels and instructions should indicate unsuitable groups.

2. Using safety standard of dry vegetables (leaf vegetables) as reference for safety index.

Acceptance date

10/07/2017,卫食新申字(2017)第0004号

Issued date

07/11/2018, passed the technical review, and issued for public comments

Approved date

29/05/2019, officially approved by Announcement No.2 of 2019

4. List of terminated reviewed products in 2019 (2 types)

A total of 2 new food ingredients were included in the termination review list in 2019. The relevant review opinions are as follows. 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."

S.N.

Product Name

Review Opinions

Acceptance Date and No

1

Clematis

(Renamed Golden thread orchid)

This product has local traditional eating habits, and it is recommended to manage in accordance with Article 29 of the Food Safety Law.

01/06/2011,卫食新申字(2011)第0013号;
30/09/2013,卫食新申字(2013)第0040号

2

Ashitaba extract

(Renamed Ashitaba Juice Powder)

NHC has approved Ashitaba as a new food raw material (Announcement No. 2 of 2019). In addition to its own production process, other product indicators can follow the announcement of Ashitaba (quality indicators are implemented in accordance with the enterprise product quality specifications).

27/09/2013,卫食新进申字(2013)第0025号

Summary:

As a member of the “Three New Foods”, 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 final formal approval, and the period from the acceptance to the issue for public comments needs at least about 1 year.

However, some new food raw materials may take a shorter time pass an application, for example, Dendrobium Officinale Protocorm, this material took only a half year from the acceptance to the issue for public comments.

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

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Note: From 2008, NHC officially accepted 360 applications of new food raw materials. 128 of them were approved, 47 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.