Infant formula milk powder has been required to be registered for the product formulation since the implementation of Food Safety Law of the People’s Republic of China on October 1, 2015. In addition, all infant formula produced domestically or exported to China must obtain a formulation registration certificate according to the law since January 1, 2018, which shall also indicate the registration number in the label and instructions.

FOODMATE therefore summarised the related regulatory information and made a guidance on registration of infant formula in China (2020), for your reference.

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1. Regulation bases

Food Safety Law of the People’s Republic of China (Order No. 21 of the President of the People’s Republic of China) (2018 revision)

Administrative measures on Product Formulation Registration of Infant Formula Milk Powder (Notice No.26 of former CFDA)

Items and Requirements of Application Materials for Product Formulation Registration of Infant Formula Milk Powder (trial) (2017 revision)  etc.

2. Relevant authorities

Acceptance body: Service hall of Administrative Acceptance of National Medical Products Administration (NMPA)

evaluation body: Centre for Food evaluation (CFE), State Administration for Market Regulation

Decision-making body: State Administration for Market Regulation (SAMR)

3. Applicants

This regulation is applicable for the registration of product formulation of infant formula milk powder which is produced and distributed in China and imported to China.


4. Number of application

No more than 3 formula series with 9 production formulation for each applicant.


5. Validity of the certificate

Valid for 5 years. No annual review or inspection.  
If the applicant want to continue using the product formulation, applicant shall apply for renewal of registration 6 months before the expiration of the certificate. 

6. Application materials

Applicant shall complete the e-application before submitting the application in paper in the service hall:

The applicant can enter the application system for product formulation registration of infant formula to fill out and print the application form at (http://samr.saic.gov.cn/) or (http://www.cfe-samr.org.cn/).

 Items and requirements of application materials for product formulation registration of infant formula　

1. List of application materials 

2. General requirements of application materials

(1）The application materials shall be printed on A4 size paper (the Chinese characters shall be in Song typeface and not be less than the 4-point font size, the English words shall not be less than the 12-point font size).

(2）Submitting application materials: 1 original, 5 copies and electronic versions
Submitting additions and corrections of the materials: 1 original, 4 copies and electronic versions


3. Specific requirements of application materials

(1) All the application materials shall be stamped with the official seal or stamp of the applicant page by page or on the perforation.

(2) The contents such as the name, address and legal representative, etc., of the applicant filled in the application materials shall be consistent with the relevant information in the evidentiary documents proving the subject qualification of the applicant, the same contents in the application materials shall be filled out always in a consistent state.

(3) Any foreign language in the application materials including the evidentiary material proving the subject qualification of the applicant, quality and safety standards for the raw and auxiliary materials, product formula, production process, inspection report, sample of labels & instructions, and relevant evidentiary documents, etc. shall be translated into normative Chinese language, the abstract, key words and contents related to the formula scientificity and safety in foreign-language references (technical documents) shall be translated into normative Chinese language (except the foreign names and addresses). The applicant shall ensure the authenticity, accuracy and consistency of the translation.

 

Items and requirements of application materials for alteration of product formulation registration

 

 

 

Items and requirements of application materials for renewal of product formulation registration

For further information on infant formula registration, please visit our service page

For guidance in Chinese, please visit

Please note: Original English article of Business Division of Food Safety and Regulatory Compliance of Global Foodmate, please indicate the source from the Global Foodmate if reprint.