Ministery of Food and Drug Safety said on the 20th that triclosan was detected at up to 0.16% in 754 of 870 batch numbers among six imported 2080 toothpaste products brought into Korea by Aekyung Industrial Co. However, triclosan was not detected in any of the 128 types manufactured domestically by Aekyung Industrial Co.

The Ministery of Food and Drug Safety says on the 20th that triclosan is detected at up to 0.16% in 754 out of 870 lot numbers across six imported 2080 toothpaste products brought into the country by Aekyung Industrial Co./Courtesy of Ministery of Food and Drug Safety

That day, the Ministery of Food and Drug Safety held a briefing at the Seoul Regional Office and announced the results of triclosan testing on all batch numbers of Aekyung Industrial Co.'s imported 2080 toothpaste and on domestically manufactured toothpaste.

Triclosan is a preservative used to prevent products from spoiling easily, and its use in oral care products has been banned in Korea since 2016. In Europe and other countries, triclosan may be used in toothpaste at 0.3% or less. The Ministery of Food and Drug Safety conducted investigations into Domy and Aekyung Industrial Co. to determine how triclosan came to be mixed into the imported toothpaste products. In Domy's earlier internal probe, the detection of triclosan in imported toothpaste products was attributed to the company's use of triclosan to disinfect toothpaste manufacturing equipment starting in Apr. 2023.

Shin Jun-su, Director General of the Biopharmaceuticals Bureau, said, "We collected and tested the 870 batch numbers available for the six imported 2080 toothpaste products manufactured since Feb. 2023 by Domy in China and brought into Korea by Aekyung Industrial Co., as well as 128 types of 2080 toothpaste manufactured domestically by Aekyung Industrial Co.," and noted, "Triclosan residue remaining on the manufacturing equipment mixed into the toothpaste products, and because the use and amount of disinfectant varied by worker, the residual levels left in the toothpaste products appeared inconsistently."

An on-site inspection of Aekyung Industrial Co. found that the company failed to comply with recall procedures, including delays in measures necessary for recall; that import quality control for overseas manufacturing sites was inadequate; and that imported toothpaste mixed with triclosan was distributed domestically. Accordingly, the Ministery of Food and Drug Safety plans to proceed with administrative disposition procedures against Aekyung Industrial Co.

Shin said, "We will strengthen inspections and monitoring at each stage of toothpaste's initial import, sale, and distribution," and added, "We will review mandating good manufacturing and quality control standards for toothpaste and establish a legal basis to impose a penalty surcharge on manufacturers and importers of harmful quasi-drugs."

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