The ministry has proposed removing the current upper limit of 100 billion CFU for daily probiotic intake, a move it says could enhance manufacturing flexibility, better meet consumer needs and strengthen global competitiveness.
However, it also emphasized that the proposal should not be interpreted as a recommendation to consume high-potency products.
“As consumer demand for various high-concentration probiotic products has recently increased, it is necessary to improve the daily intake standards to reflect international trends,” the ministry communicated in the proposal. “Doing so could expand consumer choice through the launch of various products and promote manufacturing autonomy and global competitiveness in the industry.”
Probiotics were ranked as the third-largest health supplement category produced by Korean companies last year, behind vitamin and mineral supplements and red ginseng. They also ranked third among the country’s supplement exports, trailing vitamin and mineral supplements and EPA and DHA.
The MFDS has opened a public consultation through Dec. 23 on the aforementioned proposal and other regulatory changes concerning health functional food formulation and manufacturing.
Formulations: The dos and don’ts
Another major proposal from the MFDS concerns how certain functional ingredients can be used together in a formulation.
Specifically, it has proposed prohibiting the use of functional ingredients that carry warning statements about liver disease.
A total of 15 ingredients will be affected by this proposed rule. They include garcinia, green tea extract, red yeast rice, green-lipped mussel oil extract complex and fermented Aspergillus oryzae.
Separately, the ministry has proposed allowing magnesium citrate, ferrous citrate and calcium methyltetrahydrofolate as ingredient sources for magnesium, iron and folic acid, respectively, in the manufacturing of health functional foods.
In addition, the MFDS may add cartilage tissue from sturgeon and skate to the list of permissible sources for mucopolysaccharide-protein complexes, as it seeks to diversify the range of raw materials for producing mucopolysaccharides and proteins based on prevailing scientific evidence.
Sturgeon is reportedly rich in eight essential amino acids and has a higher crude protein content than pork and eggs.
Microbial testing and manufacturing standards
The other component of the proposal concerns microbial testing and manufacturing methods of health functional foods like ginseng and EPA and DHA.
For instance, the ministry has proposed changing the standard unit for bacterial count of ginseng liquid concentrate from mL to g.
“Although ginseng and red ginseng concentrates are liquids, their high viscosity makes it difficult to measure them in volume units, so improvements to related standards are necessary,” the MFDS stated.
The ministry also called for more diverse manufacturing methods and use of the latest technology for EPA and DHA-containing oils.
Currently, EPA and DHA-containing oils must be extracted from raw materials using heating, pressing, hexane or supercritical carbon dioxide extraction and subsequently filtered. Alternatively, they may be produced by subjecting the extracted oils and fats to esterification.
The ministry has proposed adding oil pressing, including centrifugation, as a new method.
“These amendments are designed to prevent adverse events—such as those potentially arising from the combined use or excessive intake of functional ingredients in health functional foods—while also expanding the scope of permissible raw materials and the range of nutritional components that can be used in the manufacturing process,” the MFDS indicated.
