South Korean ministry proposes removing probiotic daily limit

The ministry has proposed removing the current daily upper limit of 100 billion CFU for probiotics to better meet consumer needs and strengthen global competitiveness, nutraingredients.com reported.

South Korea Seeks Higher Probiotic Potency Standards

The proposed changes, which are open for public consultation through December 23, aim to give manufacturers greater autonomy as consumer demand for high-concentration supplements continues to climb. Probiotics currently represent the third-largest health supplement category produced by South Korean companies, trailing only vitamin and mineral supplements and red ginseng. They hold the same rank among the country’s export categories.

“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 stated in its proposal.

Despite loosening the potency cap, the agency emphasized that the regulatory update should not be misconstrued as a directive to consume ultra-high-dose supplements.

Formulation Restrictions and New Material Sources

Alongside the probiotic changes, the ministry has proposed prohibiting the use of functional ingredients that carry warning statements regarding liver disease. This rule would impact a total of 15 ingredients, including green tea extract, garcinia, red yeast rice, green-lipped mussel oil extract complex, and fermented Aspergillus oryzae.

At the same time, the ministry is expanding options for other functional ingredients. The amendment would permit magnesium citrate, ferrous citrate, and calcium methyltetrahydrofolate as sources for magnesium, iron, and folic acid. Cartilage tissue from sturgeon and skate could soon join the list of permissible sources for mucopolysaccharide-protein complexes.

Scientific literature notes that sturgeon is rich in essential amino acids, carrying a higher crude protein content than pork and eggs.

Manufacturing Updates and Microbial Testing

The regulatory overhaul addresses practical hurdles in production and testing. For ginseng liquid concentrate, the ministry proposed shifting the standard unit for bacterial count from milliliters to grams, acknowledging that high viscosity makes volume measurements difficult.

Manufacturers of EPA and DHA-containing oils would also gain new production flexibility. The proposal adds oil pressing, including centrifugation, to existing extraction methods like heating, pressing, hexane use, and supercritical carbon dioxide extraction.

These amendments are intended to prevent adverse events stemming from excessive intake or ingredient combinations while widening the scope of raw materials available to producers.

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