On June 15, 2021, the State Administration for Market Regulation (SAMR) has compiled and formed the "Questions and Answers on the Registration of Infant Formula Milk Powder Product Formula", which is hereby released.

1. From the date of the issuance of the new national standard, can the applicant apply in accordance with the National Food Safety Standard, Infants Formula (GB 10765-2010) and the National Food Safety Standard, Older Infants and Young Children Formula (GB 10767-2010) for product formula registration (including change and renewal)?

Answer: Yes. But after February 22, 2023, when the "National Food Safety Standard, Infants Formula" (GB 10765-2021), "National Food Safety Standard, Older Infants Formula" (GB 10766-2021), "National Food Safety Standard, Young Children Formula" (GB 10767-2021) (Hereinafter referred to as the "New National Standard") implement, Manufacturers should organize production according to the new national standard. It is recommended that applicants should comprehensively consider the time limit for registration application acceptance, review and approval.

2. If the applicant adjusts the registered product formula according to the new national standard, under which circumstances will the formula be handled as change and under which circumstances will the original formula be cancelled to apply for new formula registration?

Answer: For the product formula that has been registered, if the applicant adjusts the formula according to the new national standard, in principle, the registration will be handled as change. For example, add choline into 0-6 months old (1 stage) formula, add compound sources of choline, selenium, manganese, vitamins, minerals, and adjust the content of active ingredients in food additive preparations into 6-12 months old (2 stage) formula.

If optional ingredients are added to or removed from the registered product formula, the formula should be cancelled to apply for new formula registration. Among them, if the formula involves 3 types of raw materials such as dietary fiber (including fructooligosaccharide, galactooligosaccharide, polyfructose, raffinose, polydextrose, yeast β-glucan, etc.), nucleotides, and bacteria that can be used in infant food, only when a certain type of raw material is added or removed (not including the adjustment of raw materials in the same category), the formula should be cancelled to apply for new formula registration.

3. If a registered product formula is applied for registration (including changes) according to the new national standard, what application materials need to be provided?

Answer: If the registered product formula is applied for registration (including changes) according to the new national standard, the following materials must be submitted:

(1) Application for registration of infant formula milk powder product formula (or application for change of registration);

(2) Relevant research and development demonstration materials for formula adjustment;

(3) Product formula;

(4) Production process description (the registration certificate states that the process needs to be submitted when there is a change in the process);

(5) Product inspection report;

(6) Research materials on product stability;

(7) Label sample.

4. What is included in the relevant research and development demonstration materials for formula adjustment?

Answer: The relevant research and development demonstration materials for formula adjustment include 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, nutrient fact, etc.), and explain the adjustment situation and reason;

(2) Food additive preparations need to provide the ingredients and their usage, as well as the implementation standards of the ingredients;

(3) No less than three batches of commercial production process verification reports;

(4) Explanation of obvious differences in formula;

(5) The control plan for pollutants, microorganisms, mycotoxins and other hazardous substances that may be contained;

(6) For the formula adding active strains, it is also necessary to submit relevant materials such as strain traceability, contamination prevention and control of miscellaneous bacteria.

5. What does the commercial production process verification report include?

Answer: Including three batches of trial production raw and auxiliary materials feeding information, as well as sample uniformity analysis, process stability analysis and nutrient compliance analysis.

6. What is included in the raw and auxiliary material feeding information in the commercial production process verification report?

Answer: Including the amount of raw and auxiliary materials in trial production, batch number, trial production date, trial production sample batch number and theoretical output, actual output, material balance accounting, etc. The dry-wet composite process should verify the complete three-batch process from the start of the wet process to the end of the finished product packaging.

7. What is included in the sample uniformity analysis in the commercial production process verification report?

Answer: Uniformity analysis refers to the uniformity analysis of samples in the same batch, such as taking at least 3 samples of trial-produced finished products at different time periods, testing the indicators that are not easy to mix in the samples and analyzing the coefficient of variation to provide uniformity determination standards, and analyzing the uniformity of the sample.

The indicators of sample uniformity analysis include at least macronutrients, vitamins, and minerals in essential components, optional components and other components that are not easy to mix. For each type of indicators, the ingredients (such as active bacteria, lactoferrin) that are added in a small amount and are not easy to be mixed should be selected.

8. What is included in the process stability analysis in the commercial production process verification report?

Answer: The stability analysis includes the following:

(1) Stability analysis between different batches, such as testing and analyzing the coefficient of variation of unstable indicators in three batches of trial production samples, providing stability criteria, and analyzing process stability.

(2) Stability analysis of the process parameters of the main production process, such as multi-batch measurement of the parameters of the main process, to determine whether the production process parameters are within the required range, so as to determine the stability of the equipment process.

9. What is included in the nutrient compliance analysis in the commercial production process verification report?

Answer: Including the analysis of at least one batch of trial production samples whether the nutrient meets the requirements of standards and label values.