The newly drafted regulations, once implemented, will replace the previous set of regulations known as “Declaration and Review of Probiotic Health Food (Trial)“.
Five main changes are introduced in the proposal, including increasing the minimum colony-forming unit (CFU) during product shelf life, the need to specify the probiotic strains used as well as their functionalities and genetic stability, etc.
The Chinese regulator said the regulations seek to ensure strain traceability and quality control.
“This revision further refines the registration and filing requirements for health foods containing probiotic ingredients and establishes a regulatory framework covering the entire chain—from strain traceability and raw material quality control to production quality assurance and viable cell testing—thereby fostering the healthy and sustainable development of the industry‚“ the SAMR wrote in its notice published on July 24.
According to the International Probiotics Association (IPA), the probiotics market in APAC is worth about US$3.7 billion, of which approximately 55% comes from China. The market is expected to achieve double-digit growth of 11% to 12%.
The five main changes proposed
One of the most striking features of the proposal is the introduction of a minimum colony-forming unit (CFU) of live bacteria during the product shelf life.
Specifically, the Chinese regulator is proposing that the total number of live bacteria should be at least 10m CFU/mL (g) in health foods containing probiotics. This is 10 times higher than the existing requirement.
Second, commercially available probiotic raw material should contain only a single probiotic strain, and all excipients used should also be listed in the product insert.
Third, companies may need to furnish their product filing or registration application with more information regarding the probiotic used, including specifying the strain designation, as well as its biology, genetics and functionality. The probiotic strain used should also be selected from China’s National Health Commission’s positive list of probiotic strains for use in foods.
In addition, companies should submit documents related to the strain’s genetic stability, drug resistance and toxin production when registering their products with the authorities.
Lastly, the regulator is proposing to include probiotic strains in the Health Food Raw Materials Directory of Nutrition Supplement. This could be done at the suggestion of individuals or companies, provided they have conducted a comprehensive evaluation of these strains.
At the moment, the Directory primarily includes vitamins, minerals and other ingredients such as fish oil, coenzyme Q10, melatonin, spirulina and Ganoderma lucidum.
When companies use a raw material listed in the Directory to develop new health food products, those products would be eligible for the filing application route, which is faster and less costly than the registration route.
