Takehome:
The first batch of approved health food raw materials has been redrafted for a second time. Changes mainly affect the number of approved compound sources and their permitted daily intake, as well as the use of premix feed.
China Health Food Premarket Guideline
Administrative Measures for Registration and Filing of Health Food
On Jun 2, 2016, China Food and Drug Administration (CFDA) announced the first batch of approved health food raw materials for public consultation for the second time ending on Jun. 11, 2016. This was already after an adjustment based on the first draft released in Feb. 2016 (see CL news report on Feb. 19, 2016).
The approved health food raw materials include 22 categories of nutrients, remaining the same as before. However, the number of approved compound sources has been increased from 61 to 67 after adjustment, all of which are approved for use in nutrient supplements. The permitted daily intake of many health food raw materials has been reset, especially maximum daily intake, including calcium, selenium, vitamin A, vitamin D, etc.
The applicable scope for retinyl acetate (vitamin A compound) has been expanded from people aged above 4 years old to all groups.
The stipulation on premix feed has been changed from “premix feed is prohibited to be used as health food raw material” to “no premix feed should be labeled”, which means that the use of premix feed in health food is now approved, however, all the raw materials and auxiliary materials of the premix feed as well as the dosage should be clearly identified in the product formula.
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