New announcement of SAMR concerning the Registration of Infant and Young Children Formula
- The new China National Standards for Infant Formula Food (GB 10765-2021), Older Infant Formula Food (GB 10766-2021), and Young Children Formula Food (GB 10767-2021) (hereafter all to referred to as ‘new GB standards’) have been published on 22nd of February 2021, and will be implemented on 22nd of February 2023.
The SAMR (State Administration for Market Supervision) has officially published the following announcement on 23rd of March 2021 concerning the Product Formula Registration of Infants and Young Children accordingly:
Starting from the publication date of the new GB standards, applicants of infant and young children formula food registration may directly use the new GB standards in their application (including changing and extension of registration). After registration, new commercial products can be produced based on the new GB standards.
Starting from the implementation date of the new GB standards, producers should produce formula which are registered according to the new standards. All products previously produced based on the old GB 10765-2010 and GB 10767-2010 can be sold in the market until their expiry date.
If an applicant wishes to change a previously registered formula to one which comply with the new GB standard, in principle it should be handled as a Change of Registration. In case which raw material (including food additives) and nutrition facts table are going to be changed, which means it will be essentially a new formula product, it shall be treated as cancellation of the original formula and an application of a new formula.
For future applications (including changing and extension of registration) of previously registered formulas, if the application concerns the new GB standards, the applicant should submit information as described in the Requirements of Product Formula Registration Application Documents of Infant Formula Milk Powder (Trial) Ver. 2017. Information which has not been changed do not need to be submitted again. In the R&D report part, detailed description about the R&D demonstration of recipe adjustment and the differences post-adjustment should be specified.
The applicant should submit information of product shelf-life and stability research. Stability research should be done by tests based on a combination of the physical and chemical properties of food raw materials (including food additives), product formulations, process conditions and packaging materials. For details it can be referred to Guidelines for Research on Stability of Infant Formula Milk Powder Products (Trial).