New regulations

Microneedle cosmetics banned from sale in Thailand (2026 notification)

9 min read · Updated 27 Oct 2026

Microneedle cosmetics in Thailand: what changed in 2026

Microneedle cosmetics in Thailand, meaning cosmetics in the form of small needles, are now cosmetics that may not be manufactured, imported or sold. The Ministry of Public Health notification was signed on 8 May 2026 (B.E. 2569) and published in the Royal Gazette on 21 May 2026. There are only two exceptions, and both apply only to dissolving microneedle patches.

Two related instruments were published the same day. One bans cosmetics containing small needle-shaped crystalline structures, often called micro-spicules. The other is a Cosmetic Committee notification setting the label warnings for dissolving microneedle patches. All three take effect from the day after publication in the Royal Gazette, and none contains a transitional clause or grace period.

This guide summarises the notification texts themselves: what is banned, what is exempt, which patches can still be notified under Thai FDA guidance, the warnings required on the label, and the route for export-only production. It is written for brand owners, importers, contract manufacturers and retailers holding stock in this category.

Thailand microneedle ban 2026: three instruments, one Gazette issue

All three instruments followed advice from the Cosmetic Committee at its meeting No. 4/2568 on 23 December 2025, and appeared in Royal Gazette volume 143, special part 128 Ngor, on 21 May 2026:

1. Ministry of Public Health notification prescribing the characteristics of microneedle cosmetics that may not be manufactured, imported or sold, B.E. 2569 (2026), issued under Section 5 paragraph one and Section 6 (1) of the Cosmetic Act B.E. 2558 (2015), signed 8 May 2026.
2. Ministry of Public Health notification prescribing the characteristics of cosmetics containing small needle-shaped crystalline structures that may not be manufactured, imported or sold, B.E. 2569 (2026), under the same sections, signed 8 May 2026.
3. Cosmetic Committee notification on label warnings for dissolving microneedle patch cosmetics, B.E. 2569 (2026), under Section 22 paragraph three, signed 2 March 2026.

Clause 1 of all three is identical: the notification applies from the day after its publication in the Royal Gazette. They therefore took effect on 22 May 2026. None of them allows existing stock to be sold off over any period, so products that fall within the ban and are still in warehouses or on shelves have had to be dealt with since that date.

Before publication, the Thai FDA cosmetics group released an infographic in April 2026 to help businesses prepare. In May 2026 the Cosmetic and Hazardous Substances Control Division issued guidance on assessing microneedle cosmetic notifications, together with a question-and-answer document. These are guidance, not law, but they show how officials apply the rules.

Which microneedle cosmetics are banned

Clause 2 of the microneedle notification starts with a broad rule: cosmetics in the form of small needles or microneedles are cosmetics that may not be manufactured, imported or sold. It then creates two exceptions:

1. Dissolving microneedle patches with needles no longer than 100 micrometres (≤ 100 µm), in cosmetics for the face and body.
2. Dissolving microneedle patches manufactured or imported for export only, not sold in the Kingdom, where the manufacturer or importer has complied with Section 35 of the Cosmetic Act.

Reading the exceptions correctly

• Both exceptions are written only for dissolving microneedle patches. Microneedle formats that are not dissolving patches fall outside both exceptions and remain cosmetics that may not be manufactured, imported or sold.
• A dissolving patch sold in Thailand must meet both conditions: needles of 100 micrometres or less, and use as a face or body cosmetic.
• A dissolving patch with needles longer than 100 micrometres does not fit exception 1. The only remaining route is manufacture or import for export only under exception 2, which is how the Thai FDA infographic summarises it too.

The notification does not say how needle length is measured. The Thai FDA notification guidance says it is measured from base to tip, and that the test report must come from a government laboratory or one accredited to ISO/IEC 17025, as explained in the notification conditions below.

Micro-spicule cosmetics Thailand: creams and serums with needle crystals

The second notification is not about patches but about formulas containing needle-shaped crystals. Clause 2 defines a cosmetic containing small needle-shaped crystalline structures as a cosmetic containing an insoluble component or substance with at least one external dimension that is a needle crystal or has a pointed shape, and that can penetrate into the body.

Clause 3 makes these cosmetics ones that may not be manufactured, imported or sold, except those manufactured or imported for export only, where the manufacturer or importer follows the criteria the Thai FDA has issued under Section 35, and the products are not sold in the Kingdom. Unlike the microneedle notification, there is no exception at all for domestic sale.

Which products are caught

The Thai FDA Q&A draws the line this way: a patch whose needles dissolve in water is a microneedle patch, while a cream, lotion or serum containing needle-shaped crystals that do not dissolve in water is a micro-spicule product. It gives ingredient names that fall in scope: SPONGE, HYDROLYZED SPONGE and SPONGILLA LACUSTRIS SPICULE EXTRACT.

In practice, brand owners need to screen every formula that uses these raw materials, not just products marketed with words like microneedle or spicule. Some products never use those words in their marketing but still contain an ingredient that fits the definition. You can start an ingredient check with our Thai FDA ingredient search.

Not on the banned substance list, but a banned characteristic

Many people look for this topic under Thai banned cosmetic substances, but the microneedle and micro-spicule notifications do not add any substance to the prohibited list. Both are issued under Section 6 (1) of the Cosmetic Act, which prescribes characteristics of cosmetics that may not be manufactured, imported or sold. The prohibited substance list is a separate instrument under Section 6 (2).

That difference changes how products are checked:

• Screening the formula against the prohibited list is not enough. A patch made entirely of hyaluronic acid may contain no prohibited substance at all, yet if its needles are longer than 100 micrometres it still cannot be sold in Thailand.
• Micro-spicules are judged by the physical nature of the ingredient: insoluble, with a needle-crystal or pointed dimension, able to penetrate the body. The ingredient name alone does not decide it.
• The label and directions are evidence too. Thai FDA guidance looks at intended use. A patch designed for a therapeutic effect is not a cosmetic in the first place.

Thailand's prohibited cosmetic substance list was also amended in the same period. To check a formula from both angles, read the latest update to Thailand's banned cosmetic ingredients. If you are unsure whether a product is a cosmetic or another product type, try our product classification tool.

Dissolving microneedle patch Thailand: conditions for notification

The May 2026 guidance from the Cosmetic and Hazardous Substances Control Division says a dissolving patch that can still be notified as a cosmetic must have these characteristics:

• Delivery to the epidermis only, a purpose that fits the cosmetic definition in Section 4, no use together with a medical device, and use on normal skin.
• Five permitted purposes: skin care, make-up, wrinkle concealment and masking for the face and body, and reducing sweat or body odour for the body, in both rinse-off and leave-on formats.
• Needles no longer than 100 micrometres from base to tip, made of water-soluble, biocompatible materials such as hyaluronic acid or trehalose derivatives.
• Single-unit containers and single use.

The same guidance says small spot patches for acne, melasma, freckles or scars intended for a therapeutic effect are not cosmetics. The Q&A adds that needle-free hydrocolloid acne patches are medical devices and need a medical device licence or detailed listing before sale.

Six documents required at notification

1. A manufacturer's statement of the main material used to make the needles
2. A detailed statement of directions for use
3. A needle length test report from a government laboratory or one accredited to ISO/IEC 17025
4. A skin irritation test report from a government laboratory or one meeting international standards such as ISO/IEC 17025 or OECD GLP, in Thailand or abroad
5. Photos of the product and every side of the label
6. A real sample of the finished product as sold

The Q&A also says that manufacturers and importers of microneedle patches do not need a classification ruling first and can file the notification directly, unless they are unsure whether the product is a cosmetic, in which case they file an online classification request with the Health Product Innovation and Services Division. For the general notification process, see how to notify cosmetics in Thailand.

Label warnings required on dissolving microneedle patches

Clause 2 of the Cosmetic Committee notification on label warnings for dissolving microneedle patches requires the label to carry at least the warnings in the box below. Manufacturers and importers may add warnings but may not drop any of them. The required text is Thai; the English lines in the box are our translation for reference.

Points to watch when preparing the label:

• Use every warning as written in the notification, without shortening it in a way that changes the meaning; for example, the restriction on children must state under 15 years of age.
• Keep the directions consistent with the warnings. Directions recommending daily use would contradict the final warning that daily use is not recommended.
• Imported products with foreign labels need a Thai label with the full warnings before they go on sale.
• Images and text on the pack must not encourage use on areas the warnings exclude, such as the lips or around the eyes.

The general Thai cosmetic label rules still apply alongside these warnings. See Thai cosmetic label requirements.

Manufacture or import for export: the Section 35 exception

The microneedle and micro-spicule notifications open the same door for foreign markets: manufacture or import for export only, with no sale in the Kingdom, in compliance with Section 35 of the Cosmetic Act, under which products made to a buyer's specification for export must still be notified.

The criteria issued under Section 35 are in the Thai FDA notification on notifying cosmetics manufactured or imported for export only (2018). Applicants file purchase evidence and the partner country's regulations, or a certificate from its government, showing the product may be sold there, and keep production or import reports on form RorNgorKor.1 for at least five years.

For micro-spicules, the Thai FDA Q&A lists the additional documents needed to manufacture for export under a partner country's law:

• A letter stating the intention to export, naming the cosmetic and the destination country
• Purchase evidence
• The partner country's regulations
• Documents on the main material of the needles or crystals
• A needle length test report from a government laboratory or one accredited to ISO/IEC 17025

Products notified for export only can never be sold in Thailand, including leftover stock from an order or goods a buyer rejects. Plan how surplus stock will be handled from the start. For the certificates that support exports, see Thai FDA export certificates for cosmetics.

What manufacturers, importers and sellers should do now

With the notifications in force and no grace period, the immediate tasks differ by role.

Brand owners and importers

• Review every notification receipt for patches, needle devices or formulas with needle-shaped crystals. The Thai FDA infographic advised businesses to review their receipts and request cancellation of those that fall within the ban.
• For dissolving patches you will keep selling, confirm the needle length test shows 100 micrometres or less and the intended use is face or body.
• Update labels to carry all six warnings from the Cosmetic Committee notification.
• Creams, lotions or serums with spicule-type ingredients must be reformulated or withdrawn from domestic sale.

Contract manufacturers

• Tell customers whose formulas are affected, and make sure export-only orders carry complete Section 35 documentation.
• Keep needle length test reports for every production batch in the product file.

Retailers and online sellers

• Check stock in the warehouse and on sale. Patches that are not the dissolving type, or that lack the required warnings, should not stay on sale.
• The Thai FDA infographic summarises that breaches carry both imprisonment and fines, for manufacturers, importers, contract manufacturers and sellers alike.

To have our regulatory team check product classification, formula and label against all three instruments, contact us. If you need to notify a new patch, see our product registration service.

Sources

1. MOPH notification on characteristics of microneedle cosmetics that may not be manufactured, imported or sold, B.E. 2569 (2026) · Open source · Search our archive
2. MOPH notification on characteristics of cosmetics containing small needle-shaped crystalline structures that may not be manufactured, imported or sold, B.E. 2569 (2026) · Open source · Search our archive
3. Cosmetic Committee notification on label warnings for dissolving microneedle patch cosmetics, B.E. 2569 (2026) · Open source · Search our archive
4. Thai FDA guidance on assessing microneedle cosmetic notifications (May 2026) · Open source · Search our archive
5. Thai FDA microneedle details and Q&A · Open source · Search our archive
6. Thai FDA infographic: preparing for the new microneedle cosmetic rules · Open source · Search our archive
7. Thai FDA notification on notifying cosmetics manufactured or imported for export only to buyer specifications (2018) · Open source · Search our archive
8. Cosmetic Act B.E. 2558 (2015) · Open source · Search our archive

This article is for general information. It is not a Thai FDA ruling or legal advice, and rules change — check the latest notification or ask an expert before filing or producing.

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