Health Food Filing and Registration in China: Recent Regulatory Updates and Case Study

On July 1, 2016, China announced the formal implementation of the new health food registration and filing system. CFDA also released relevant supplementary requirements thereafter. This article contains updated information on impact of these rules with a particular emphasis on detailing conditions where under the new rules previously registered products would now be subject to filing requirements (comparatively reduced regulatory compliance burden). 

Some Background

The definition of Health food in China is “Food Products which claim to have a specific health function or supplement one’s vitamins or minerals. Health food is suitable for the consumption by specific groups of people and has the effect of regulating human body functions, but is not used for the purpose of treating diseases, which will not have any form of harm whether it is acute, sub-acute or chronic to human body.”
In the Chinese law, it is divided in two subcategories: Health food with functional claims that have physiological effects on the human body and nutrient supplements with vitamins and minerals as major ingredients but without providing energy or other active ingredients. In talking about health food regulation in China, registration and filing are two distinct procedures that have a different scope. Health food with functional claims requires registration, while nutrient supplements require filing, introduced in order to provide a procedure faster than registration. For imported health foods produced in oversea manufacturers, both registration and filing shall be applied with CFDA.

What are the most relevant recent changes?

After the announcement on the 17^th of November 2016 of the update of the rules for the registration of health food, China CFDA on 12^th January 2017 released finalized version of the first batch of approved health food raw materials (vitamins/minerals and regulated dosages).
The substances included in this list are all subject to health food filing rather than health food registration. The approved health food raw materials include 24 categories of nutrients and 69 approved compound sources, all of which are approved for use in nutrient supplements. The permitted daily intake of many health food raw materials has also been reset, especially maximum daily intake, including calcium, selenium, vitamin A, vitamin D, etc. Nutrients and compound not listed are not approved for use unless added later. In addition, on 2 May 2017, China’s CFDA also finalized and released the “Health Food Filing Guidance”, as well as auxiliary material directory for health food filing and major production techniques. CFDA has been accepting health food filing application since May 1, 2017.
 
Change of online declaration of health food