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Myanmar Regulatory Update: FDA Issues a Cosmetic Safety Alert over a Lip Tint Testing Positive for Banned Rhodamine B

Nov 4, 2026
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On November 2, 2026, the Food and Drug Administration (FDA) of the Ministry of Health of Myanmar released a Public Notice on Cosmetics Not Suitable for Use, reporting that a lip tint sold on the Myanmar market and not registered with the Myanmar FDA tested positive for the banned dye Rhodamine B.

The Myanmar FDA is the cosmetics regulator under the Ministry of Health of Myanmar. According to the notice, the Myanmar FDA, under the guidance of the Ministry of Health, exercises systematic oversight so that the public can use cosmetics of good quality that are free from health hazards. The notice was issued after the Myanmar FDA tested cosmetics on sale in the domestic market, and it concerns one product.

Interpretation of Rhodamine B 

Rhodamine B (CAS No. 81-88-9; Colour Index (CI) No. 45170) is a fluorescent xanthene dye that appears as a red to purplish-red powder. It is mainly used as an industrial dye and tracer.

Under the ASEAN Cosmetic Directive (ACD), Rhodamine B is listed among the substances prohibited in Annex II and may not be used as a cosmetic ingredient. China's Cosmetic Safety Technical Specifications, as well as major cosmetic markets such as the European Union, likewise list it as a prohibited ingredient.

The Myanmar FDA states in the notice that the use of such products may cause symptoms including skin irritation (itching), skin ulceration, rashes or papules; the ingredients may be absorbed through the skin into the body and cause harm, and may also lead to muscle tremors, fatigue and weakness, and depressed mood. Long-term use may cause kidney damage and induce other diseases.

Requirements for Operators and Follow-up Supervision

The notice requires companies that import, distribute and sell cosmetics, as well as wholesale and retail outlets and online sellers, not to import, distribute or sell cosmetics that are not registered with the Myanmar FDA and have been announced as unsuitable for use, stressing that this is a code of ethics (Ethic) that operators should observe. The Myanmar FDA also stated that it will continue to strengthen market inspections in the relevant regions and states.

CIRS Reminder

  • Companies exporting cosmetics to Myanmar, or selling products to the Myanmar market through cross-border e-commerce and online platforms, should verify whether the products concerned have been registered with the Myanmar FDA;
  • Review supply chains and products on sale to avoid purchasing or selling products of unknown origin, products with incomplete label information, or products in packaging that imitates well-known cartoon characters;
  • Conduct self-checks on formula compliance to confirm that products do not contain banned dyes such as Rhodamine B and that all colorants used fall within the permitted lists.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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Further Information:

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