In recent years, probiotics have received more and more attention. Probiotic health foods are also very popular as microbial products that supplement probiotics exogenously. Since the implementation of health food registration in China in 1996, more than 100 probiotic health foods have obtained registration approval. Compared with tens of thousands of registered health foods, the proportion of probiotic health foods is too small. CIRS made a detailed analysis on registered probiotic health foods in China, aiming to help enterprises better understand the registration situation of this kind of products.
By the end of 22 April 2020, 137 health foods using probiotics as the main raw material in China have obtained health food registration approval (including the newly approved products through technology transfer).
The cultures used in probiotic health foods mainly come from Lactobacillus and Bifidobacterium. 107 products contain Lactobacillus in the formula, the culture of these products is mainly Lactobacillus acidophilus with the number of 81. 98 products contain Bifidobacterium in the formula, the cultures of these products are mainly Bifidobacterium longum and Bifidobacterium animalis (Bifidobacterium lactis) with the number of 33 and 22, respectively.
Most probiotic health foods contain two or more species of cultures, and some combinations are relatively common, such as the combination of Bifidobacterium longum and Lactobacillus acidophilus (28), Bifidobacterium animalis (Bifidobacterium lactis) and Lactobacillus acidophilus (17), etc.
(Note: the product information of 8 new registered products have not been published, and 5 products lack the generic name.)
Figure 1 The Number of Approved Probiotic Health Food with Different Cultures
The 129 probiotic health foods include: 1) 74 products with single health function, the health function of these products is mainly enhancing immune, with the number of 40, accounting for 54.05% of the 74 products; 2) 53 products with two health functions, the health functions of these products are mainly enhancing immune and regulating gastrointestinal tract flora, with the number of 27, accounting for 50.94% of the 53 products; 3)2 products with three health functions (approved in 1996 and 1997, respectively).
(Note: Considering the replacement of health function name, the statistic is based on the current health function names, and the old similar functions are included in current health functions for statistic, e.g., “immunoregulation” is included in “enhancing immunity”.)
Figure 2 The Number of Approved Probiotic Health Food with Different Health Functions
The dosage forms of probiotic health foods are relatively few, mainly including powder/granule/electuary, capsule, liquid milk/beverage, tablet and oral liquid, and is mainly powder/granule/electuary, with the number of 70, accounting for 51.09% of the total, followed by capsule and liquid milk/beverage with the number of 31 and 19, accounting for 22.63% and 13.87% of the total, respectively.
Figure 3 The Number of Approved Probiotic Health Food with Different Dosage Forms
As a special kind of health food, the application requirements and test items of probiotic health food are more complex and strict, which makes it more difficult to obtain registration approval. SAMR issued Application and Review of Probiotic Health Food (Draft) in 2019, which specifies the definition of probiotics, and focuses on the safety and functionality review of probiotics on the strain level. Relevant regulations such as Pathogenicity Assessment Procedure of Strains for Health Food (Draft) and Toxicological Assessment Procedure of Health Food (Draft) have also been issued. The regulations and technical standards of probiotic health foods are already in the stage of update and improvement, thus, the registration of relevant products would be smoother in future. (For more information about probiotic health food, please click Current Situation of Regulations and Application Requirements on Probiotic Health Food in China)
CIRS will continue to pay attention to the release of relevant new regulations and the approval of new products. Meanwhile, applicants should strengthen their understanding on the regulations and policies as well.
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