On May 21, 2026, the Royal Thai Government Gazette (Volume 143, Special Part 128D, Page 18) published a notification signed by the Department of Medical Sciences, Ministry of Public Health, pursuant to Section 27 of the Cosmetics Act B.E. 2558 (2015), specifying the labeling requirements for Dissolving Microneedle Patch products.
Key Content
The notification provides the following definitions:
- Dissolving Microneedle Patch: A cosmetic product in the form of a patch containing microneedles that dissolve upon contact with the skin, used for cosmetic purposes.
- Microneedle: A needle-like structure with a length not exceeding 0.5 millimeters, made from a material that dissolves upon contact with the skin.
Labeling Requirements
The labeling of dissolving microneedle patches must comply with the following requirements:
- The product name must clearly indicate it is a "Dissolving Microneedle Patch"
- Must include warning statements: For external use only; Do not apply to broken or irritated skin; Discontinue use if irritation occurs; Keep out of reach of children
- Must indicate the duration of use (e.g., use within 24 hours after opening)
- Must indicate storage conditions (e.g., store in a cool, dry place; avoid direct sunlight)
- Must indicate batch number and expiration date
- Must indicate the name and address of the manufacturer or distributor
Regulatory Background
This notification is part of Thailand's enhanced regulatory framework for microneedle cosmetic products. Previously, the same gazette included Dissolving Microneedle Patch and Microneedle Patch in the Cosmetic Ingredient Directory (Appendix 1), with a needle length limit of 100 μm (0.1 mm) and restricted to skin surface use only. This labeling notification further specifies the labeling standards for microneedle patch products, ensuring consumers receive adequate product information and usage warnings.
Effective Date
The notification was published in the Royal Thai Government Gazette on May 21, 2026, and takes effect upon publication in accordance with the Cosmetics Act B.E. 2558 (2015).
CIRS Reminder
Thailand is progressively strengthening its regulatory framework for microneedle cosmetic products. It is worth noting that there is a discrepancy in needle length definitions between the two notifications — the Ingredient Directory limits needle length to ≤100 μm (0.1 mm), while the labeling notification defines it as ≤0.5 mm. Companies should monitor for any subsequent clarifications or amendments. Additionally, this labeling requirement applies only to Dissolving Microneedle Patches; the labeling requirements for non-dissolving Microneedle Patches remain unclear. Companies exporting or selling microneedle cosmetic products to Thailand should promptly assess product compliance to ensure labeling meets the latest regulatory requirements.
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:
Royal Thai Government Gazette
