The National Food Safety Standard Infant Formula (GB 10765-2021), National Food Safety Standard Older Infants Formula (GB 10766-2021) and National Food Safety Standard Young Children Formula (GB 10767-2021) (hereinafter collectively referred to as the new national standards) were released on February 22, 2021, and will be implemented on February 22, 2023. In order to do a good job in the product formula registration of infant and young children formula milk powder after the issuance of new national standards, the announcement regarding registration matters is as follows:

1. From the date of the issuance of new national standards, the applicant can submit an application for product formulation registration (including change and renewal) in accordance with new national standards, and can product according to the new national standards after obtaining registration. From the date of the implementation of new national standards, manufacturers should product according to the product formula registered in accordance with new national standards. Previously, the products produced according to the National Food Safety Standard Infant Formula (GB 10765-2010) and National Food Safety Standard Older Infants and Young Children Formula (GB 10767-2010) can be sold until the end of the shelf life.

2. For the registered product formula, if the applicant adjusts the formula according to new national standards, in principle, it shall be handled as change registration; at the same time, if the applicant adjusts the types of formula raw materials (including food additives) and the nutrition information, which essentially constitutes a new product formula, it shall be handled as canceling the original formula to apply for the registration of new formula.

3. For the registered product formula, if the applicant applies for registration according to new national standards (including change and renewal), documents should be submitted according to the Application Material Items and Requirements for Formula Registration of Infant and Young Children Formula Milk Powder (For Trial Implementation) (2017 Revision), and documents that have not been changed do not need to be resubmitted. In the R&D demonstration report of product formula, both the R&D demonstration of formula adjustment and the differences after the adjustment should be explained in detail.

4. The applicant should submit research documents of product stability during the shelf life. To ensure product quality and safety, stability research should be designed reasonably combining with the physical and chemical properties of food raw materials (including food additives), product formula, process conditions and packaging materials. For details, please refer to the Guidelines for Research of Product Stability of Infant and Young Children Formula Milk Powder (For Trial Implementation).

For the interpretation of New National Standards, please click 

- New Standards of Infants Formula Landing.

If you want to know more about infant formula registration requirements and the copy of Guidelines for Research of Product Stability of Infant and Young Children Formula Milk Powder (For Trial Implementation), please contact us!

Lillian Fan

Tel: 010-51301566

email: Lillian.fan@antion.net

More details about Announcement please click the link below

http://gkml.samr.gov.cn/nsjg/tssps/202103/t20210324_327214.html