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1.    Background introduction

Food Safety Law of the People’s Republic of China (2009) (Revised on April 24, 2015). According to Food Safety Law, for production of new food additive varieties, the producer shall submit the safety assessment materials relative to the product to the National Health and Family Planning Commission (NHFPC).

NHFPC shall organize the review of the materials within sixty (60) days upon receipt of the application. For applications that comply with food safety requirements, a license shall be granted and made public. For applications that fail to comply with the safety requirements, a license shall not be granted with an explanatory note in writing.

NOTE: NHFPC has been replaced by National Health Commission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

2.    What are new food additives?


  
2.1 Definition

New varieties of food additives refer to:

1)      Varieties of food additives not listed in the national food safety standards;

2)      Varieties not included in the List of Approved Food Additives as issued by the Ministry of Health;

3)      Varieties of food additives with extended application scope or amount of usage.

2.1 Characteristic
       The use of food additives shall comply with the following requirements:

1)      The putrefaction and deterioration of food may not be covered;

2)      The quality defect in food or production process may not be covered;

3)      The food additives are not used for the purpose of adulteration, sophistication or counterfeiting;

4)      The nutritive value of food may not be reduced;

5)      Under the precondition that the desired effect is achieved, the dosage of food additive shall be reduced as much as possible;

6)      The processing agents used in food industry shall be removed before the finished products are obtained, unless a residual quantity is allowed for such agents. 

 
3. Regulatory framework for new food additives in China
 
Relevant regulations
 
Measures for the Administration of New Varieties of Food Additives
Provisions on the Declaration and Acceptance of Food Additives
Announcement on Regulations of License Administration for New Species of Food Additive
Food safety National Standard Standards for Uses of Food Additive
Administrative department
National Health Commission 

4. New food additives registration
4.1 Registration procedure

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NOTE: yr means year; wd means working days

4.2 Materials submitted for new food additives registration

Materials submitted

1       Application form

2       Common name, functional classification, usage amount and range of application

3       Supporting materials or documents to confirm the technical necessity of the new variety and its applying effects

4       Requirements on quality and specification, productive technology and test methods, test method specially used for the new additive in food and other information on relevant aspects

5       Safety evaluation materials, including raw materials or sources, chemical structure and physical characteristics, productive technology, toxicological safety evaluation materials or survey report, survey report on quality and specification

6       Drafts of label or instruction

7       Materials contribute to safety evaluation, permitted to produce and use by other countries (regions), international organizations

Additional materials submitted for initial import

1       The supporting documents of the permission of production or sale of the food additive in the local place, which is issued by relevant agency or institute of exporting country (region)

2       The supporting documents of examination or accreditation of the original manufacturer issued by relevant agency or institute of the host country (region)

3       The entrusted applicant shall provide the letter of authorization for the entrusted application

4       Chinese version shall be notarized by relevant Chinese notary organizations


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Ø  For the edible new spice, it may be exempted from submission of the information mentioned in (2) and (3) for application
Ø  Supporting materials about technical necessity:

1)      Functional categories and mechanism of action of food additives;

2)      Comparison of the effect of food with and without additives;

3)      Comparison of the use effect with food additives falling into the same functional category;
       4)      Other technically necessary information. 

Ø about : If there is no currently valid food additive product criterion for new species of food additive under application, the following documents with respect to quality specifications shall be submitted:

1)      Food additive product standard documents (including the authentication, major technical indicator requirements and relative test methods);
       2)      The preparation instructions;

3)      Comparison with the relevant standards of international organizations and other countries (regions);
       4)      The validation of test methods.

5. Special tips about new food additives


Ø  For compliance with food safety requirements, the Health and Family Planning Commission has decided to grant permission to publish new food additive varieties, use ranges and amounts, and also publish the quality specifications for new food additive products as a basis for the organization of production. After the corresponding national food safety standards are issued, the quality specifications for food additives are immediately invalidated.
Ø In case that the same applicant applies for more than one new varieties of the food additive, the applicant shall apply for them respectively based on their different varieties.
 
6. Our Service

Service
Content
 
 
Required document
 
review & correction
 
Ø Step by step process guideline
Ø Collect and analyze materials from client
Ø Supplement and revision opinions
Ø Advice on modification in order to meet China statutory requirements
 
 
Sample inspection
Ø Sample receiving and tracking
Ø Arrange sample inspection
Ø Track inspection progress & handles problems
Ø Inspection report review  
 
Dossier preparation
Ø Build up dossier storyline structure 
Ø Consolidate draft from English to Chinese
 
Dossier Submission
online submission
On-site submission
 
 
Progress following up
Ø Follow up the CFDA review process
Ø 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. 
 
 
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