MFDS Announces Administrative Sanctions Over Triclosan in 2080 Toothpaste

Triclosan has been detected in roughly 87% of six imported 2080 toothpaste products that Aekyung Industrial had manufactured in China and brought into Korea. Triclosan, which has been at the center of controversy over potential hormone disruption and other health risks, has been completely banned from use in toothpaste and other oral care products since 2016. According to the Ministry of Food and Drug Safety (MFDS) on the 20th, it collected and tested 870 batch numbers of six imported 2080 toothpaste products manufactured by Chinese company Domy since February 2023 and brought into Korea by Aekyung Industrial, along with 128 types of 2080 toothpaste manufactured domestically by Aekyung Industrial. As a result, Triclosan was detected at levels of up to 0.16% in 754 batch numbers among the imported toothpaste products. In contrast, none of the 128 types manufactured domestically by Aekyung Industrial contained any detectable Triclosan. To address consumer concerns, MFDS also separately collected and tested 128 types of domestically produced 2080 toothpaste made by Aekyung Industrial. The products subject to recall by Aekyung Industrial are six items: 2080 Basic Toothpaste, 2080 Daily Care Toothpaste, 2080 Smart Care Plus Toothpaste, 2080 Classic Care Toothpaste, 2080 Triple Effect Alpha Fresh Toothpaste, and 2080 Triple Effect Alpha Strong Toothpaste. Triclosan is a preservative ingredient used to prevent products from spoiling easily. In Korea, its use in oral care products has been completely banned since 2016. MFDS conducted investigations into Domy and Aekyung Industrial to determine how Triclosan came to be mixed into the imported toothpaste products. The investigation into Domy found that Triclosan was detected in the imported toothpaste because the company began using Triclosan in April 2023 to disinfect its toothpaste manufacturing equipment. An on-site inspection of Aekyung Industrial revealed several issues: delays in taking necessary measures for the recall and failure to comply with recall procedures, inadequate quality control over imported products from overseas manufacturing sites, and the distribution in Korea of imported toothpaste containing Triclosan. Accordingly, MFDS plans to proceed with administrative sanction procedures against Aekyung Industrial. However, MFDS explained that, based on expert consultation, the risk of harm from using toothpaste containing Triclosan at levels of 0.3% or less was assessed to be low. In fact, in regions such as Europe, toothpaste containing Triclosan at concentrations of 0.3% or lower has been evaluated as being within a safe range. MFDS plans to strengthen testing, inspections, and monitoring at each stage of initial import, sale, and distribution of toothpaste. This comes amid criticism that there were blind spots in the management of quasi-drugs, as Triclosan testing was not included among the test items that companies are required to check on their own. In particular, MFDS is reviewing the introduction of mandatory manufacturing and quality control standards for toothpaste and will establish a legal basis for imposing punitive surcharges on manufacturers and importers of hazardous quasi-drugs. Importers will be required to submit Triclosan test reports when toothpaste is first imported, and self-quality testing for Triclosan will be made mandatory for each batch number at the point of sale. In addition, at the distribution stage, MFDS announced that it will expand collection and testing by conducting an annual full-scale survey of all imported toothpaste products to determine whether they contain Triclosan. This article has been translated by GripLabs Mingo AI.