Q: Does the applicant need to submit the product shelf-life stability research documents if applying for registration change? Does stability research need to submit accelerated test and long-term test at the same time?
A: If the registered product formula is adjusted according to the new national standards, no matter whether it is registered as change or new formula, the shelf-life stability research documents are required. Applicants can submit research documents of accelerated test or long-term test.
Q: With reference to the Guideline for Stability Research of Infant and Young Children Formula Milk Powder Products (For Trial Implementation) (hereinafter referred to as the Guideline), what are the specific requirements for the samples used in the stability research?
A: The sample used in stability research shall be produced under commercial production conditions, and in principle, it shall be the same batch as the sample used in production process verification. If different batches are used, the reasons shall be explained.
Q: When making the product shelf-life stability research, what are the requirements for the verification documents of the self-built method used if there is no GB testing method?
A: If self-built test method is used, verification and documents submission can refer to the Conformity Assessment Validation and Verification of Chemical Analytical Methods (GB/T 27417-2017).
Q: Does the product shelf-life stability research have to be completed on its own? Can the test items of stability research be commissioned by a third-party testing agency? What qualifications does the third-party inspection agency need to have?
A: The applicant shall have R&D ability of formula, and the product shelf-life stability research needs to be completed on its own. The test items of stability research can be tested by themselves and/or entrusted to a third-party testing agency according to the actual situation, and the reasons for entrusting a third-party testing agency shall be explained. The third-party testing agency shall have the qualifications for testing items and be responsible for the test results.
Q: What does it means that “for some active bacteria that are not suitable for accelerated test conditions, historical long-term data from similar formulas with the same water activity can be used for analysis” in the Guideline?
A: If the active bacteria added in the formula are the same before and after the adjustment according to the new national standards, 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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