SAMR | Q&A on Registration of Infant formula milk powder product formula (3)


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. Today is the final part.

15. How to understand "the materials that have not changed will not be submitted repeatedly"?

Answer: After the registered product formula is adjusted according to the new national standard, the materials that have not changed will not be resubmitted. If the raw materials and food additive implementation standards have not changed, they cannot be resubmitted (except for food additive preparations); If the registration certificate states that the process has not changed, the production process description may not be submitted repeatedly; If the control plan for pollutants, microorganisms, mycotoxins and other hazardous substances that may be contained is not changed, the materials may not be resubmitted.

16. Does the applicant need to submit the product shelf-life stability study materials if the applicant applies for changing registration? Do I need to submit accelerated tests and long-term tests at the same time I submit the stability study?

Answer: If the registered product formula is adjusted according to the new national standard, no matter whether it is registered for changing formula or for the new formula, the shelf life stability study materials are required. Applicants can submit either accelerated tests or long-term tests.

17. According to the "Guidelines for Stability Research of Infant Formula Milk Powder Products (Trial)" (hereinafter referred to as the "Guide"), what are the specific requirements for the samples used in the stability study?

Answer: The samples used for stability study should be produced under commercial production conditions. In principle, it is the same batch of samples used for production process verification. If different batches are used, the reasons should be explained.

18. When studying the shelf-life stability of a product, what are the requirements for the verification materials of the self-built method for the non-GB testing method used?

Answer: If you use self-built testing methods, you can refer to "Conformity Assessment-Guidance on validation and verification of chemical analytical methods" (GB/T 27417-2017) for verification and submit verification materials.

19. Does the product shelf-life stability study have to be done by us own? Can the stability study test project be entrusted by a third-party inspection agency for testing? What qualifications does the third-party inspection agency need to have?

Answer: The applicant should have the research and development ability of the formula, and the product shelf life stability study needs to be completed by the applicant. The test items in the stability study can be tested by applicants and/or entrusted to a third-party inspection agency according to the actual situation. The reasons for entrusting a third-party inspection agency shall be explained. The third-party inspection agency must have the qualifications for testing items and be responsible for the testing results.

20. How to understand the "Guide" "For some active bacteria that are not suitable for accelerated test conditions, the historical long-term data of similar formula under the same water activity can be used for analysis"?

Answer: If the active bacteria added in the formula are the same before and after the adjustment of the new national standard, and there is no significant difference in water activity, the historical long-term data of the registered formula of the same applicant before the adjustment can be used for analysis.

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