1. From the date of issuing the new national standards, can the applicant apply for product formula registration (including change and renewal) according to "National food safety standard Infant formula" (GB 10765-2021), "National food safety standard Older infant formula" (GB 10766-2021) and "National food safety standard Young children formula" (GB 10767-2021)?

Answer: Yes. However, since the implementation date (February 22, 2023) of "National food safety standard Infant formula" (GB 10765-2021), "National food safety standard Older infant formula" (GB 10766-2021) and "National food safety standard Young children formula" (GB 10767-2021), the manufacturers shall organize the production according to the product formula registered by the new national standards, and it is suggested that the applicants comprehensively consider the time limit of acceptance, review and approval of the registration application.

 

 

 

 

2. For the registered product formula, if the applicants make adjustments according to the new national standards, which cases are handled as change? which cases are handled as the cancellation of original formula and applying for new formula registration?

 

Answer: For the registered product formula, if the applicant adjusts the formula according to the new national standards, it shall be handled as change of registration in principle, such as adding choline to the products for the age of 0-6 months (Stage 1), adding the compound sources of choline, selenium, manganese, vitamins and minerals to the products for the age of 6-12 months (Stage 2) and adjusting the content of effective ingredients in food additive preparations.

 

If the optional ingredients are added to or removed from the registered product formula, it shall be handled as the cancellation of original formula and applying for new formula registration. Among them, if the three categories of raw materials such as dietary fiber (including fructooligosaccharide, galactooligosaccharide, polyfructose, raffinose, polydextrose, yeast β-glucan, etc.), nucleotides, and bacteria permitted for use in infants and young children foods are involved, only when adding or removing a certain type of raw materials (not including the adjustment of raw material variety within the same category), it shall be handled as the cancellation of original formula and applying for new formula registration.

 

 

 

 

3. If a registered product formula is subject to applying for registration (including change) according to the new national standards, what application materials need to be provided?

 

Answer: If the registered product formula is subject to applying for registration (including change) according to the new national standards, the following materials need to be submitted:

 

(1) Application for registration of infants and young children formula milk powder product formula (or application for change of registration);

 

(2) Research and development demonstration materials related to formula adjustment;

 

(3) Product formula;

 

(4) Production process description (it needs to be submitted when the registration certificate states that there are changes in the process);

 

(5) Product inspection report;

 

(6) Product stability research materials;

 

(7) Label sample.

 

 

 

4. What contents are included in the research and development demonstration materials related to formula adjustment?

 

Answer: The research and development demonstration materials related to formula adjustment include the following contents:

 

(1) Provide the list of the adjustment contents (such as the standard for raw materials and food additives, table for formula composition and dosage, and nutrition facts, etc.) compared with the registered formula, and explain the adjustment situation and reasons;

 

(2) For food additive preparations, it needs to provide the composition and usage amount, as well as the executive standards for the composition;

 

(3) Commercial production process verification reports of not less than three batches;

 

(4) Description of significant difference in formula;

 

(5) Control plans for contaminants, microorganisms, mycotoxins and other possible hazardous substances;

 

(6) For the formula with addition of active bacteria, it also needs to submit relevant materials such as strain traceability and prevention and control of miscellaneous bacteria contamination, etc.