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On 26 January 2017, CFDA released two supplementary documents for infant formula milk powder formula registration relating to labeling and stability research for public comments. Opinions and advises shall be given before 20 February 2017. Generally, the stability research during the formula registration includes influencing factors test, accelerated test, long-term test, etc. Here CIRS will focus on the Stability Guideline, to help you better understand the relevant important stability research requirements.

1. Influencing factors test

Enterprise can take 1 batch of samples to conduct the influencing factors test. Generally, it includes high-temperature test, high humidity test and Illumination test.

Tests	General condition
High-temperature test	Ø Temperature: 60℃ Ø Duration: 10 days Ø Sampling time: the 5th day and the 10th day If the samples changed significantly, the temperature can change to 40℃.
High humidity test	Ø Temperature: 25℃ Ø Humidity: RH90％±5％ Ø Duration: 10 days Ø Sampling time: the 5th day and the 10th day If the hygroscopic weight is more than 5%, the condition can change to 25℃, RH75％±5％.
Illumination test	Ø Illumination: 4500Lx±500Lx Ø Duration: 10 days Ø Sampling time: the 5th day and the 10th day

PS. If the conditions are differing from above, the relevant scientific basis shall be provided.

2. Accelerated test

Enterprise shall take 3 batches of samples to conduct the accelerated test.

Items	Requirements
Test duration	At least 1/4 of the production shelf life, and at least 3 months.
Sample time	Take the 6 months test duration as a sample: The sampling time shall be at 0 month, 1 month, 2 months, 3 months and 6 months. Among them, the test data of 0 month samples can be replaced with the quality test results of the same batch.
Test condition	Temperature: ≥40℃ Humidity: ≥RH75％

PS. If the conditions are differing from above, the relevant scientific basis shall be provided.

3. Long-term test

Enterprise shall take 3 batches of samples to conduct the long-term test.

Items	Requirements
Test duration	At least as long as the expected shelf life.
Sample time	I. At the end of every 3 months in the first year, at the end of every 6 months in the second year II. Take product with shelf life of 24 months as a sample: The sampling time shall be at 0, 3, 6, 9, 12, 18, 24 months. Among them, the test data of 0 month samples can be replaced with the quality test results of the same batch.

PS. 1. If the conditions are differing from above, the relevant scientific basis shall be provided.

2. The long-term test can be started together with the accelerated test. The registration applicant can submit the registration application when the accelerated test is finished, and promise to continue to complete the long-term test.

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Reference: http://www.sfda.gov.cn/WS01/CL0782/169260.html.

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China CFDA Drafts Guidelines for the Stability Research of Infant Formula Milk Powder Formula Registration