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 referred to as the new national standards), will be implemented on February 22, 2023. In order to do a good job in formula registration during the transition period of the new national standards, the SAMR issued the Announcement of the SAMR on Matters Concerning the Product Formula Registration of Infant and Young Children Formula Milk Powder (No. 10 of 2021), which clarified the classification management of registration and application, formula adjustment and R&D during the transition period. In order to further guide applicants to scientifically carry out formula R&D and trial production, and to standardize the application of registration documents, the SAMR has compiled and formed the Q&A on Product Formula Registration of Infant and Young Children Formula Milk Powder, which is hereby released.
What contents are included in the R&D demonstration information related to formula adjustment?
The R&D demonstration information related to formula adjustment includes the following:
(1) Comparison of the list with the adjustment content of the registered formula (such as raw material and food additive standards, formula composition and dosage table, nutrition information), and explanation of the adjustment situation and reason;
(2) Food additive preparations need to provide the components and their dosage, as well as the implementation standards of components;
(3) No less than three batches of commercial production process verification report;
(4) Explanation of obvious differences of formulas;
(5) The control plan for pollutants, microorganisms, mycotoxins and other hazardous substances that may be contained;
(6) For the formula where active strains are added, it is also necessary to submit documents related strain traceability, contamination prevention and control of miscellaneous bacteria.
What contents are included in commercial production process verification reports?
It includes three batches of trial production raw and auxiliary materials feeding information, as well as analysis of sample uniformity, process stability and nutritional components compliance.
What contents are included in raw and auxiliary materials feeding information in commercial production process verification reports?
It includes the feeding amount of raw and auxiliary materials in trial production, batch numbers of raw and auxiliary materials, trial production date, trial production sample batch number and theoretical yield, actual yield, material balance accounting. The dry-wet composite process shall verify the complete three-batch processes from the start of the wet process feeding to the end of the final product packaging.
What contents are included in the analysis of sample uniformity in commercial production process verification reports?
The analysis of uniformity refers to the analysis of sample uniformity in the same batch. For example, taking at least 3 samples of trial-produced final products at different time periods, test and analyze the coefficient of variation of the indicators that are not easily mixed in the samples, provide uniformity determination standards, and clarify the uniformity of samples.
The analysis indicators of sample uniformity include at least macronutrients, vitamins, and minerals in essential components, optional components and other components that are not easily mixed. For each indicator, the components (such as active bacteria, lactoferrin) that are added in a small amount and are not easily mixed shall be selected.
What contents are included in process stability analysis in commercial production process verification reports?
The stability analysis includes the following:
(1) The stability analysis among different batches, such as testing and analyzing the coefficient of variation of unstable indicators in three batches of trial production samples, providing stability determination standards, and clarifying process stability.
(2) The stability analysis of the process parameters of the main production procedures, such as multi-batch determination of the parameters of the main process, to judge whether the production process parameters are within the required scope, so as to determine the stability of the equipment process.
What contents are included in the analysis of nutritional components compliance in commercial production process verification reports?
It includes the analysis of at least one batch of trial production samples whether the nutritional components meet the requirements of standards and label values.
More interpretation about New Standards, please click New Standards of Infants Formula Landing.
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Hongtao Fei
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