MFDS Bans Key Ingredient in Modamoda Shampoo Raw Material

Manufacturing Allowed Only Until 6 Months After Administrative Notice in the First Half of This Year

[Asia Economy Reporter Ki Ha-young] The Ministry of Food and Drug Safety (MFDS) has decided to add '1,2,4-trihydroxybenzene' (1,2,4-THB), the key ingredient in Modamoda shampoo that self-colors hair, to the list of prohibited cosmetic ingredients.

The MFDS announced on the 26th that, following the conclusion of the administrative notice for the 'Regulations on Safety Standards for Cosmetics,' it will proceed with the amendment process to designate 1,2,4-THB as a prohibited ingredient in cosmetics and add it to the list. After subsequent procedures such as regulatory review, the amendment is expected to be completed within the first half of this year, and six months after the amendment date, the ingredient will no longer be allowed for use in cosmetic manufacturing.

1,2,4-THB is an ingredient included in hair dye products, appearing as a light beige powder. It dissolves well in water and reacts with oxygen in the air to turn black, making it mainly used in hair coloring agents.

The MFDS conducted experiments to evaluate the safety of 1,2,4-THB, including non-clinical genetic toxicity, skin irritation, skin sensitization, reproductive and developmental toxicity, and skin absorption. As a result, 1,2,4-THB was assessed as a substance that cannot exclude the potential for 'genetic toxicity,' which causes mutations in genetic material (DNA). It was also found to have mild skin irritation and skin sensitization effects.

However, it was explained that ▲ no significant hazards were confirmed in other test categories such as reproductive and developmental toxicity, and ▲ considering that Europe added it to the prohibited list and is enforcing manufacturing and sales bans with transitional measures in place.

At expert advisory meetings, it was also evaluated that the possibility of genetic toxicity of 1,2,4-THB could not be excluded, and it was concluded that it is reasonable to ban the use of genetically toxic substances regardless of usage amount or environment. Even though it is a rinse-off shampoo, since it is massaged directly onto the scalp, which has pores and a high absorption rate, and considering the frequent use characteristics of shampoo, it was suggested that it is difficult to judge the absorption rate as low.

The MFDS stated, "We will continue to conduct hazard assessments of 'cosmetic ingredients' and monitor foreign regulatory trends to ensure the supply of safe cosmetics to the public."