During the period from Mar. 20 to April 20, 2019, China's SAMR opened public consultation on Application and Evaluation of Probiotic Health Food (Consultation Draft) to solicit comments from the public. As a result, a total of 135 suggestions proposing changes to the draft version were received, of which 101 were considered valid suggestions. 97 were rejected, and 4 were proposed to be adopted or partially adopted.
Among the four recommendations, one is about the number of viable probiotics, two are about the implementation date, and the last is about the source of inspection report. Details are as follows:
1. The competent authority partially accepts the suggestion that the number of viable probiotics of each type of probiotic health food within its shelf life should be raised from at least 106CFU/mL (g) to no less than 107 CFU/mL (g).
According to the 'Natural Health Products Probiotics' (Canada) and the 'Guideline to Probiotics and Prebiotics' (Italy), the effective daily consumption of probiotics should not be less than 107CFU/ day and 109CFU/day respectively. Based on the recommendations of other countries and the approval status of probiotic health food in China, it is recommended that the total number of viable probiotics should not be less than 107CFU/mL (g).
2. The implementation date of 'Probiotic Health Food Registration & Evaluation Provision' will be further clarified, and mainly involves the following 2 aspects:
The proposed implementation date should be consistent with the release and implementation of the supporting inspection and evaluation technical specifications
The original test should still be effective, that is, if the test is accepted before the implementation date, then it shall follow the original testing requirements. Product evaluation could comply with new regulation while the original test report shall be accepted if test is involved.
3. The authority will follow advice to add more qualified inspection institutions in China or accept data and reports generated by international testing institutions.
This suggestion is raised due to currently insufficient testing & inspection resources in China.
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