Recently, China SAMR published a series of notifications regarding requirements for filing of health food product using the five functional ingredients (i.e., coenzyme Q10, reishi shell-broken spore powder, spirulina, fish oil and melatonin, hereafter referred to as "the Five Ingredients"), which have been added into the health food raw material positive list earlier in 2020. These notifications specified dosage forms and technical requirements for filing, and provided explanations on some filing issues.
Dosage forms and technical requirements
The Notification Regarding Dosage Forms and Technical Requirements of Health Food Filing Using the Five Ingredients (hereafter referred to as "Technical Requirements") released on Feb.1 of 2021 specified the dosage forms, auxiliary materials and technical requirements (physicochemical indicators, active ingredients, microorganism indicators, etc.) allowed for filing of health food using the Five Ingredients. This notification will come into effect on Jun. 1, 2021.
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