Taiwan Cosmetic Regulations and the Sudan Red Issue

· Regulations
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As of late November 2025, Taiwan has faced its first major incident of Sudan Red detection in cosmetics, breaking the previous stereotype that Sudan Red was solely a "food safety (chili powder)" issue.

This incident has affected several well-known Taiwanese brands (such as Greenvines and O'right), primarily because the "plant extracts" imported by upstream raw material suppliers were adulterated with industrial dyes.

Below is a summary of the current status of Taiwan's cosmetic regulations and an in-depth analysis of this Sudan Red storm:

I. Core Regulatory Framework: Cosmetic Hygiene and Safety Act

In Taiwan, the enforcement basis for such incidents is the Cosmetic Hygiene and Safety Act.

1. Legal Status of Sudan Red

Under Taiwan's cosmetic regulations, Sudan Red (Sudan I, II, III, IV) is classified as a "Prohibited Ingredient in Cosmetics."

Legal Basis: According to Article 6 of the Act, cosmetics must not contain prohibited ingredients such as mercury, lead, or Sudan Red.

Nature: It is an industrial azo dye (used in floor wax, petrol coloring), known to be genotoxic and potentially carcinogenic. It is strictly prohibited for use in products intended for human contact.

2. Penalties and Liability (Enforcement regarding the 2025 Incident)

In this incident, the Ministry of Health and Welfare's Food and Drug Administration (TFDA) has imposed heavy penalties:

Importers (The Source): The importer of the problematic raw materials, Yihong Enterprise, was directly fined the maximum penalty of NT$ 5 million for failing to fulfill verification responsibilities and for the wide scope of impact. They have also been referred to prosecutors for investigation (involving criminal liability).

Brand Owners (Downstream): Brands are required to immediately remove and destroy non-compliant products. Failure to recall within the deadline can result in fines ranging from NT$ 10,000 to NT$ 1 million.

II. Analysis of the 2025 Taiwan Cosmetic Sudan Red Storm

This event differs fundamentally from the past "Chili Powder" incidents; it is a major warning signal for the cosmetic supply chain.

1. Source and Pathway of Contamination

Problematic Raw Material: Red ingredients labeled as "Natural Plant Extracts" (e.g., Holy Basil, Chili Extract).

Pathway: Singapore Supplier (Campo Research) $\rightarrow$ Taiwan Importer (Yihong) $\rightarrow$ Taiwan Brand Factories (Greenvines, O'right, GP Deva, etc.).

Reason: Natural pigments (like anthocyanins, carotenoids) have poor stability, are expensive, and fade easily. Unscrupulous upstream manufacturers illegally added the industrial dye Sudan Red to make the materials appear "vibrant and long-lasting" while lowering costs.

2. Why were famous brands affected?

This exposed a blind spot in testing. Historically, cosmetic inspections focused on "Heavy Metals," "Microbes," and "Preservatives." Since Sudan Red theoretically should never exist in cosmetics, it was not part of the routine check items for brand owners, leading them to use contaminated raw materials unknowingly.

3. Health Risks for Consumers

Although the skin absorption rate is lower than ingestion, risks remain:

  • Lip Products (High Risk): If lip balms or lipsticks contain Sudan Red, there is a high risk of ingestion, equivalent to consuming Sudan Red chili powder.
  • Skin Contact: Long-term contact may cause allergic dermatitis, and due to its fat-soluble nature, there is still a risk of penetration.

III. Response Strategies for Enterprises and Consumers

Advice for Consumers (How to Protect Yourself)

Check the Product List: Be sure to cross-reference the recall list published by the TFDA. As of December 2025, affected products are mostly "Red/Pink" lip oils, lip glazes, and some serums claiming to contain plant extracts.

Stop Using Related Products: If you possess specific batches of products like Greenvines' "Lip Oil (Berry Red Edition)" or O'right's "Hair Tonic," please stop using them immediately and contact the brand for a return.

Be Rational about "Natural": Be vigilant with "natural" products that have excessively vibrant and persistent colors, as natural pigments usually oxidize and fade more easily.

Insights for the Industry (Regulatory Compliance Direction)

Importance of PIF (Product Information File): Taiwan's regulations have fully implemented the PIF system. Operators must rigorously audit the COA (Certificate of Analysis) provided by raw material suppliers.

Expand Testing Scope: Brand owners need to include Sudan Red in their self-inspection items for high-risk raw materials (especially red plant extracts).

Supplier Management: Do not rely solely on reports from foreign original manufacturers; third-party re-verification is necessary.

Conclusion

This incident shows that while Taiwan's cosmetic regulations are strict (maximum fine of 5 million), there are still loopholes in the raw material management of the global supply chain. For consumers, if you see a product labeled "Natural Pigment" that is unusually vibrant and does not fade, you should remain skeptical.