Guidance on Registration of Infant Formula in China (2020)
May 02, 2020
Infant formula milk powder has been required to be registered for the product formulation since the implementation of Food Safety Law of the Peopleâs 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.
1. Regulation bases
Food Safety Law of the Peopleâs Republic of China (Order No. 21 of the President of the Peopleâs 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)
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/).