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On February 20, 2021, China State Administration for Market Regulation published the Dosage Forms and Technical Requirements for Health Food Filing (2021 Edition) (hereafter referred to as "the Technical Requirements") and the List of Auxiliary Materials for Health Food Filing and Terms of Use (2021 Edition) (hereafter referred to as "the List"). These regulations will take effect on Jun. 1st, 2021.
In August 2020, SAMR consulted on the use of gelatinized confection and powder in health food subject to filing (see CL news here). The two documents released this time officially approve the usage and provide the list of auxiliary materials and technical requirements of corresponding dosage forms.
Technical requirements of various dosage forms
Technical requirements for tablets, capsules, oral solutions, and granules should refer to the Chinese Pharmacopoeia and GB 16740 National Food Safety Standard Health Food;
As the forms of gelatinzed confection and powder belong to ordinary food and currently there is no corresponding GB standard, they should comply with the technical requirements specified in the appendixes, which involve sensory requirements, physical and chemical indicators and microorganism indicators, product specification, and etc.
When it comes to the five health food raw materials approved for filing in December, 2020, (coenzyme Q10, melatonin, fish oil, reishi shell-broken spore powder, and spirulina), they should follow Dosage Forms and Technical Requirements of Health Food Filing Using the Five Ingredients published on Feb. 1, 2021 (see CL news here).
The list of auxiliary materials
The 2021 List replaces the 2019 edition and adds 1 auxiliary material item on its basis. Currently there are 197 items in total. As there are two new dosage forms now, the 2021 edition also supplements some notes on the usage of auxiliary materials for gelatinized confection and powder, summarized as follows:
46 auxiliary materials cannot be used for gelatinized confection;
25 auxiliary materials cannot be used for powder;
The reference standards of the Chinese Pharmacopoeia of 29 auxiliary materials are not applicable for either gelatinized confection or powder;
The maximum limits of 15 auxiliary materials used in gelatinized confection are specifically indicated in the list, which are lower than that used in other solid dosage forms.
It is also noteworthy that the 2021 List slightly changes the definition of liquid preparation from "oral liquid and drops with the maximum daily consumption of 30ml" to "oral solutions with the maximum daily consumption of 30ml (currently oral liquid and drops)". It indicates the possibility of new liquid dosage forms in the future.
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