The Ministry of Food and Drug Safety designates 1,2,4-trihydroxybenzene as a prohibited ingredient in cosmetics.

The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) revised the ‘Regulations on Cosmetic Safety Standards, etc.’ and designated 1,2,4-trihydroxy benzene (THB) as a prohibited ingredient in cosmetics. and announced that it would be added to the banned list.

This is a measure based on the results of THB's safety verification. The verification was conducted by the Cosmetics Raw Material Safety Verification Committee operated by the Korea Consumer Organization Council. The Regulatory Reform Committee recommended verification of the safety of THB on March 25 last year.

▲ Modamoda Black Shampoo containing 1,2,4-trihydroxybenzene (THB). The Ministry of Food and Drug Safety designates THB as a prohibited ingredient in cosmetics.

The Cosmetics Raw Material Safety Verification Committee is comprised of experts in skin, toxicity, law, and media. Experts in each field reviewed domestic and foreign toxicity data on THB, data submitted by the Ministry of Food and Drug Safety, and data submitted by Modamoda. The verification committee concluded that the possibility of genotoxicity of THB could not be ruled out. A safety verification report containing this conclusion was submitted to the Ministry of Food and Drug Safety.

Accordingly, from December 7 to 11, the Ministry of Food and Drug Safety issued an administrative notice to revise the ‘Regulations on Cosmetic Safety Standards, etc.’ adding THB to the list of prohibited ingredients in cosmetics. The notice is scheduled to be revised after regulatory review by the Regulatory Reform Committee.

If the notice is revised, THB cannot be used in the manufacture of cosmetics. Products manufactured before the revision can be sold until October 1, 2024.

The Korea Consumer Organization Council said, “To evaluate the safety of THB, we comprehensively reviewed the SCCS (European Scientific Committee for Consumer Safety), the EU report, the Ministry of Food and Drug Safety risk assessment report, and data submitted by related companies. “We concluded that THB has the potential to be genotoxic,” he explained.

He continued, “There is no threshold for THB due to its genotoxic potential, so the toxicity standard cannot be determined. It is impossible to set safety standards for human exposure to THB. There are concerns about safety if consumers continue to use it. “It is reasonable to prevent the use of THB as a cosmetic ingredient as a preventive measure,” he said.

The Korea Consumer Organization Council recommended that Modamoda prepare a voluntary recovery plan, such as recalling products containing THB. He said that compensation measures should be prepared for consumers who have suffered side effects from the product.

In response to this, Modamoda has not yet announced a recall or refund plan for black shampoo. The company emphasized through a pop-up window and notice on its official website on December 6 that ‘Zero Gray Black Shampoo’, which was released in October, and not black shampoo, was a product that complied with the Cosmetics Act.

Modamoda said, “Zero Gray Black Shampoo is a product that complies with the standards set by the Cosmetic Act. “It did not contain 12 types, including 1,2,4-trihydroxybenzene and o-aminophenol.”