The Status Quo of Imported Health Food Registration/Filing in China as of 2021 H1

1.  Registration/filing in 2021 H1 

In the first half of 2021 (by June 30), only two imported health food products obtained the filing certificates issued by SAMR, while no imported health food was granted registration approval. Compared to the filing performance of 2020 H1, the number of imported health food products obtained filling certificates drops sharply.

Table 1 Imported Health Food Products Obtained Filing Certificates Issued by SAMR

2.  Overview of Registration/filing Performance 

Since China introduced dual-track system for imported health food (filing & registration) in 2017, 138 imported health food products have obtained filing approval so far.

However, after 17 imported health food products successfully obtained registration approval in 2017, imported health food registration suffers from stagnation since 2018, even not a single product has passed the registration.

Note: The data is from Special Food Information Query Platform. Due to the lag of information release by the competent authority, the actual number of approved filing may be inconsistent with the data above. 

3.  Analysis of the Registration/filing Trend 

In 2020, China SAMR added five new functional ingredients (namely, coenzyme Q10, reishi shell-broken spore powder, spirulina, fish oil and melatonin) into the health food raw material positive list. (Check the ChemLinked News for more details.) On Feb. 1, 2021, SAMR released “Dosage Forms and Technical Requirements of Health Food Filing Using the Five Ingredients Including Coenzyme Q10” as a supportive document, which specified the dosage forms, auxiliary materials and technical requirements for the filing of health food using coenzyme Q10, reishi shell-broken spore powder, spirulina, fish oil and melatonin. At present, such filing requirements only apply to domestic products. For imported products using the five ingredients, registration is still required. Notably, Zhang Zhongpeng, director of Health & Nutrition Department, CCCMHPIE (China Chamber of Commerce for Import & Export of Medicines & Health Products), recently revealed that there has been some internal discussions among competent authorities over the registration of imported health food products using the five ingredients at ChemLinked's Food Digital Week. He implied that SAMR might consider providing further convenience for those imported products, and to simplify the registration process may be the feasible option. 

In addition, SAMR published “Dosage Forms and Technical Requirements for Health Food Filing (2021 Edition)” and “List of Auxiliary Materials for Health Food Filing and Terms of Use (2021 Edition)” on Feb. 20, 2021. Both of them has come into force on Jun. 1, 2021. The two regulations stipulate that gelatinized confection and powder can be used for health food filing, and provide the list of auxiliary materials and technical requirements for corresponding dosage forms. It is noteworthy that the updated auxiliary material list for health food filing now includes 197 items, among which 46 cannot be used for gelatinized confection and 25 cannot be used for powder. (Check the ChemLinked News for more details.) With the implementation of these regulations, enterprises are given greater freedom on the production of health food products, and more products become qualified for filing, which may help enterprises obtain more filing approvals in the future. Check China Imported Health Food Filing Directory for the latest filing status quo.