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1.Background introduction

1.1 The regulation history of novel food ingredient in China

图片1

1.2 The regulation history of novel food ingredient in China
Table1Distribution of novel food ingredient approved for each year
Year
Amount
2008
11
2009
15
2010
38
2011
14
2012
11
2013
18
2014
20
2015
0
2016
6
2017
10
2008-2017
143


Table2Distribution of novel food ingredient sources
Source
Amount
Per
Animal, plant and microorganism
78
55%
Isolated from animal, plant and microorganism
44
31%
Food ingredients with the change of original structure
3
2%
Other developed food materials
18
12%
Total
143
100%

For example:

     Plant source: Lepidium meyenii Walp, Borojo powder

     Microorganism source: Lactobacillus reuteri, Kluyveromyces marxianus

     Plant isolated source: Aqueous Extract of Seed of Broccoli, Zeaxanthin

     Microorganism isolated source: Gamma-linolenic Acid Oil, Sialic acid

     Animal isolated source: Hyriopsis cumingii polysaccharide, Earthworm Protein

1.3 Registration duration after dossier submission

图片2加水印

1.4 Warning about declaration of new food ingredient

According to “the NHFPC on modifying the decision of the administrative rules such as the < Administrative measures for safety review of new food ingredient > "(December 5, 2017), For those passing the review on safety evaluation documents of new food ingredient and obtaining the license through improper means such as cheating and bribery, National Health and Family Planning Commission will revoke the license. And the applicant shall not re-apply for New food ingredient within three years.

2. What is novel food ingredient?

 

New food ingredients refer to the following articles without the traditional food habit in China,

 Animal, plant and microorganism;

 Ingredients separated from animal, plant and microorganism;

 Food ingredients with the change of original structure;

 Other developed food materials.

New food ingredients referred to in the Administrative Measures on Safety Review of new food ingredient exclude new types of transgenic foods, health foods and food additives. new food ingredient shall have the characteristics of food materials and comply with nutritional requirements, and shall be nontoxic and non-hazardous, and free from any acute, sub-acute, chronic or other potential harm on human health.


3. Regulatory framework for novel food ingredient in China
Relevant regulations
 
Food Safety Law of the People’s Republic of China (2009) (Revised on April 24, 2015)
Administrative measures for safety review of new food ingredient
Declaration and acceptance stipulations of new food ingredient
Safety review procedures of new food ingredient
Administrative department
 
National Health and Family Planning Commission (NHFPC)

Note: NHFPC has been replaced by National Health Commission (A picture to know the changes of china's food regulation structure)


4. Novel food ingredient registration

4.1 Registration procedure

Novel food 加水印

4.2 Materials submitted for Novel food ingredient registration

Materials submitted
 Application table
 Development report of new food ingredient
 Safety evaluation report
 Production process
 Related executive standards (including safety requirements, quality specification and test methods and so on)
 Label and user instruction
 Domestic and foreign research and utilization as well as the related safety evaluation documents
 Other documents helpful to review
 One sealed product sample or 30 g material shall be provided additionally
Additional materials submitted for initial import
 The proof document issued by the competent department or institution of the exporting country (region) to allow this product to be used for the production or sales in this country (region)
 The proof document issued by the competent department or institution of the country (region) of the production enterprise about the review or certification of the production enterprise

Note: yr means year; wd means working days

4.3 Probable conclusions from XXX for registration

1) Suggested for approval:

2) Terminated for approval:

· Managed as food

· Managed as food and in accordance with specified implementation standard

· Substantial equivalence: managed as food or new food ingredient that have been approved

· Managed as recognized traditional consumption history

3) Suggested for non-approval:

· Without the characteristics of food materials

· Not conforming to the nutritional requirements

· Security cannot be guaranteed

· Declaration materials or samples are not true

· Other conditions that do not comply with relevant laws and regulations of China
 

5. Our services

Content
 
Required document
review & correction
 
 Step by step process guideline
 Collect and analyze materials from client
 Supplement and revision opinions
 Advice on modification in order to meet China statutory requirements
 
Sample inspection
 Sample receiving and tracking
 Arrange sample inspection
 Track inspection progress & handles problems
 Inspection report review  
Dossier preparation
 Build up dossier storyline structure 
 Consolidate draft from English to Chinese
Dossier Submission
online submission
On-site submission
 
Progress following up
 Follow up the CFDA review process
 Face to face talking with CFDA and supplement required documents accordingly
 Remarks: All of the above documents originally from Foodmate, please indicate our source if reprint. 
Contacts

CHINA(Beijing)

TEL:010-68869850
Email:global-service@foodmate.net
ADD: W. 4th Ring Road North No.160 Haidian Beijing China

 

CHINA(Yantai)

TEL: 0535-2129301
Email:hanking@foodmate.net
ADD: West area, Donghe Technology Park, No. 229 Tongshi South Road, Zhifu District, Yantai City, Shandong Province

 

SWIZERLAND

Tel: +41 784034643
Email: EUoffice@foodmate.net
ADD: Churerstrasse 92i, CH-8808, Pfaeffikon SZ, Switzerland

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