Taiwan FDA Issues Warning on Banned Cosmetic Colorant Sudan 4

On November 21, 2025, Taiwan’s Food and Drug Administration (FDA) confirmed the detection of the banned colorant Sudan 4 (CI 26105) in imported cosmetic ingredients. The FDA has ordered all affected products to be removed from the market and urged manufacturers and distributors to strengthen supply chain control to reinforce regulatory compliance and ensure the safety in of cosmetic products.

Sudan 4 Recognized as Hazardous and Banned in Cosmetics

• Sudan 4 (CI 26105) is a synthetic azo dye that is prohibited for use in all cosmetics under Taiwan’s Cosmetic Hygiene and Safety Act.
• The dye is associated with potential carcinogenicity and poses health risks when applied to the skin.
• Regulatory limits require that Sudan 4 must not be detectable in any cosmetic product.

Regulatory Measures and Enforcement

• All products containing Sudan 4 must be withdrawn from sale immediately.
• Manufacturers and distributors are required to review their supply chains to ensure that their raw materials are free from prohibited substances.
• Violations of the Cosmetic Hygiene and Safety Act may result in fines ranging from NT$20,000 to NT$5 million, as well as the mandatory recall and destruction of non-compliant products.

Consumer Safety Guidelines

• Consumers are advised to stop using any cosmetic products suspected of containing Sudan 4.
• Medical attention should be sought if skin irritation, redness, itching, or other adverse reactions occur.
• Consumers are encouraged to choose products that are legally registered and have clear ingredient sources to minimize health risks.
• Adverse reactions can be reported through the FDA’s Post-Market Quality Management System: http://qms.fda.gov.tw/tcbw/ or by calling the hotline: 02-2521-5027.