China’s health foods filing: Only two overseas firms received approval in first seven months of 2022 – new data
Between January 1 to July 5, China’s regulator State Administration for Market Regulation (SAMR) had approved a total of 1,483 health foods filing applications. Of which, only two went to imported products.
The two products were 1) a multivitamins and mineral tablet from Jamieson Laboratories and 2) Healthy Care’s zinc and vitamin C chewable tablet which comes in strawberry flavour.
This is according to an analysis of China’s health foods filing by Hangzhou-based regulatory consultancy firm CIRS.
Health foods filing is applicable to products that contain raw materials listed in China’s Health Food Raw Materials Directory and are made into either tablets, capsules, oral liquid, granules, powder or gummies.
Once approved, these products could be sold offline in China as well as in local e-commerce platforms. As compared to the alternative procedure of health foods registration, this is a less expensive and time-consuming procedure.
Local Chinese firm Weihai Baihe Biology Technological (威海百合生物） had received the highest number of health foods filing – with 61 filings granted, followed by Weihai Nanbowan Biology (威海南波湾生物技术) with 33 filings, and China Resources Shenghai Health Technology (华润圣海健康科技) with 31 filings granted.
Since health foods filing was implemented in year 2017, the overwhelming majority of the products that have received approval were from China.
Some of the reasons were because the overseas companies lacked understanding of China's regulatory requirements and the documents submitted did not satisfy the requirements, said CIRS.
Performance of newly added raw materials
On the other hand, the number of health foods containing co-enzyme Q10, fish oil, melatonin, spirulina, or Ganoderma lucidum as a single ingredient product and were approved via the filing process has hit 571.
The five raw materials were added into the Health Food Raw Material Directory and applicable for health foods filing since March last year.
Of which, the majority of them (199) contained Ganoderma lucidum, another 149 contained co-enzyme Q10, 106 contained melatonin, 92 contained fish oil, and 25 contained spirulina.
Another 348 approved health foods filings were for multivitamins, 336 for health foods containing single nutrient and 226 for health foods containing dual nutrients.
Gummies and powder were the two new formats applicable for health foods filing since June last year. Between January to July 5 this year, there were 49 and 98 gummies and powder approved via the filing process respectively.
In general, most of the health foods approved via filing were made into the form of tablets (652) and capsules (531), followed by oral liquids (78) and granules (73).