SAMR Publishes Following-Up Supervision Measures for Infant Formula Recipe Registration Under the New GB Standards

On March 18, 2021, China NHC released the new national food safety standards for infants formula. (See the interpretation of new infant formula standards here.) On March 24, 2021, SAMR released the following-up notice¹ regulating the infant formula recipe registration under the new GB standards. There are mainly four points.

1. Manufacture and selling issues during grace period are clarified.

As of the promulgation date of the new GB standards for infant formula (see e-translations in ChemLinked Database), applicants can submit the registration/alteration/renewal application to China’s authority and produce IF products after obtaining the approval. Starting from the implementation date of these new standards (Feb. 22, 2023), enterprises should manufacture IF products based on new standards, but products produced before the implementation date are still allowed to be sold within its shelf life.  

2. Conditions for recipe registration/alteration are settled.

To recipes that have already obtained the registration approval, when applicants adjust the recipes according to the new standards, procedures of alteration should be followed in principle; if ingredient (including food additives) species and the nutritional facts of recipes were both adjusted, which becomes a new product recipe virtually, then applicants should annul the original recipe first and register the recipe as a new one.

3. Legal basis for the submission of documents is provided.

To recipes that have already obtained the registration approval, when applicants want to apply for recipe registration, alteration and renewal under the new standards, they should provide relevant materials and documents based on the requirements specified in “Items and Requirements of Application Materials for Registration of Infants and Young Children Milk Powder Formula Recipes (Trial) (2017 Revised Edition)” (See English translation in ChemLinked Regulatory Database). Materials and documents without any changes are exempted from the submission. As for the recipe research&development argument report, R&D argument of the recipe adjustment, together with the differences before and after the adjustment, should be explained in details. 

4. A new requirement has been raised: product stability research

Applicants should submit a research material about the product stability within the shelf life. The research should be designed rationally and take following factors into consideration, such as the physicochemical property of food ingredients (including food additives), product recipe, manufacturing technique and package materials. Check the newly released guideline “Research Guideline for Infant Formula Milk Powder Product Stability” for reference.