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SAMR Notice on Registration of Infant and Young Children Milk Powder Products with the New National Standard

from CIRS by


On March 24, 2021, SAMR issued the following notice concerning the registration of infant and young children formula milk powder products:

GB 10765-2021, GB 10766-2021 and GB 10767-2021 (hereinafter referred to as ‘the new standards’) have been issued on February 22, 2021 and will be implemented on February 22, 2023. In order to facilitate registration works of infant formula milk powder products after the release of the new standards, the following matters are hereby announced:

1. Since the release of the new standards, applicants can apply for product formula registration (including change and extension) according to the new standards, and the production can be organized according to the new standards after successfully registered. From the implementation date of the new standards, the manufacturers shall organize the production according to the product formula registered based on the new standards, and the products previously produced according to GB 10765-2010 and GB 10767-2010 can be sold to the end of the shelf life.

2. For the registered products, if the applicants adjust the formula according to the new standards, in principle, the change registration shall be handled; At the same time, if adjusting raw materials (including food additives) and nutrition table, which is essentially constituting a new product formula, the cancellation of the original formula shall be made and the applicant shall apply for new formula registration.

3. For the registered product formula, if the applicant applies for registration according to the new standards (including change and extension), the applicant shall submit the materials according to Application Materials for Registration of Infant Formula Milk Powder Product (Trial) (2017 Revised Edition), and the materials without change shall not be submitted again. In the product formula R&D report, the formula adjustment and the differences before and after adjustment shall be specified in detail.

4. The applicant should submit the product shelf life stability study materials. Stability study should be based on the physical and chemical properties of ingredients (including food additives), product formula, processing conditions and packaging materials, etc. For details, please refer to Guidelines for Study on Stability of Infant Formula Milk Powder Products (Trial) (see the appendix from official link for details) to ensure product quality and safety.

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