Analysis of the Registration Application of New Food Raw Material (Novel Food) in 2019 - Regulatory News - Food & Food Contact Materials

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	衛食新申字(2019)第0001號	Xylan
2	12/06/2019	衛食新申字(2019)第0002號	Dendrobium Officinale Protocorm
3	10/10/2019	衛食新申字(2019)第0003號	Rumex dapibus herba by.
4	09/12/2019	衛食新申字(2019)第0004號	Lactobacillus kefiranofaciens ZW3
5	09/12/2019	衛食新申字(2019)第0005號	Idesia polycarpa oil
6	13/12/2019	衛食新申字(2019)第0006號	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, 衛食新申字(2016)第0012號

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，衛食新進申字(2013)第0030號

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，衛食新進申字(2013)第0032號

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，衛食新進申字(2013)第0031號

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, 衛食新申字(2019)第0002號

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, 衛食新進申字(2015)第0009號
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，衛食新申字(2016)第0010號
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，衛食新申字(2017)第0004號
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，衛食新申字(2011)第0013號； 30/09/2013，衛食新申字(2013)第0040號
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，衛食新進申字(2013)第0025號

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.

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

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.

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