FDA Thailand How to notify cosmetics with the Thai FDA: a step-by-step guide from formula to notification number
What Thai cosmetic notification is, and who must file
Thai cosmetic notification is the filing of a cosmetic's details with the authority before it is manufactured or imported for sale. Under the Cosmetic Act B.E. 2558 (2015), anyone manufacturing, importing or contract-manufacturing cosmetics for sale must notify first and may start only after receiving the notification receipt. The receiving officer is the Thai FDA Secretary-General or a delegate.
Foreign companies often call this "Thai FDA cosmetic registration", but cosmetics use a notification system rather than drug-style registration. The result is a notification receipt and number, which must appear on the label and is valid for three years from issue.
Exemptions
The Act exempts manufacture or import for samples, exhibitions, or study, research and analysis, subject to ministerial conditions. Manufacture for export to a buyer's specification still requires notification, and such products may not be sold in Thailand.
Step 1: confirm the product is legally a cosmetic
Before filing, confirm that the product is a cosmetic under Thai law; if it is not, it cannot be notified and must be authorised under another law. The Thai FDA's cosmetic notification criteria (revised 2021) use a five-point test, and failing any one means the product is not a cosmetic:
- the formula contains no banned substances and uses permitted substances within legal limits;
- it is applied to the external body, or the teeth and mouth;
- its main purpose fits the cosmetic definition;
- it does not state a purpose of treating or preventing disease;
- it has no lasting effect that restores or changes body function through pharmacological, immunological or metabolic action.
The criteria give examples of non-cosmetics: products to reduce fat or dissolve cellulite, to regrow hair, brows or lashes, products used with needles or devices to push substances through the skin, nasal or throat sprays, and insect repellents. If unsure, run a first check with the product classification tool.
Step 2: screen the formula against the Thai lists
The first test requires no banned substances and restricted substances within legal limits. Before filing, check every ingredient against the Thai FDA lists: banned substances, restricted substances, preservatives, UV filters and colourants.
- Use INCI names, because labels and filings use the names from the references set by the Thai FDA.
- Check both identity and concentration; some substances are allowed only in certain product types or require label warnings.
- For nanomaterials, the explanatory note on the labelling notification requires "(nano)" after the name and, at filing, documents such as a specification or certificate of analysis showing particle size of 100 nanometres or less.
Screen the whole formula with the formula checker and look up single substances in the substance search.
Step 3: applicant eligibility and premises (cosmetic import Thailand)
The Ministry of Public Health notification on cosmetic notification, receipts, renewal, amendment and replacement B.E. 2561 (2018) sets applicant rules:
- an individual must be a Thai national aged 20 or over;
- a company must be registered in Thailand;
- the applicant must have a manufacturing or import site that meets the notification on manufacturing or import criteria.
A foreign brand therefore cannot notify directly. A Thai importer, individual or company, must be the notifier. For Thai brands using a contract manufacturer, both parties have legal duties, and the manufacturing contract must be attached.
Manufacturing or import premises
The 2018 notification on manufacturing or import criteria requires manufacturing sites to have at least two separate rooms, separation from living quarters and permanent signage. Import and storage sites must be separate from living quarters and signed as a cosmetic import site and a cosmetic storage site. See what is GMP for details.
Step 4: Thai cosmetic notification documents
The schedule to the 2018 notification lists the supporting documents. Applicants typically prepare:
| Group | Documents |
|---|---|
| Premises | House registration copies for the office, manufacturing or import site and storage site (with a lease if rented) |
| Business | Commercial registration, health-hazard business licence or factory licence, and site inspection result |
| Company | Company certificate issued within the last 6 months |
| Contract manufacture | Manufacturing contract |
| Import | Authorisation from the brand owner or foreign manufacturer |
| Drug-like containers | Photos of every side of the label if packed in ampoules or vials |
Importers should also prepare foreign documents for their Annex B duties under the manufacturing or import criteria, such as evidence that the source plant meets ISO 22716 or ASEAN Cosmetic GMP, and certificates of analysis for the product information file. Screen documents with the import document checker.
Step 5: notify cosmetics Thailand with form JK.1
When the formula, premises and documents are ready, file the notification on form JK.1
- at the Thai FDA;
- at the provincial public health office where the business is located;
- through the Thai FDA online system.
The name, trade name, type and formula entered must match the label and the actual product, because the Cosmetic Act requires products to be made or imported exactly as notified.
Product names
The notification criteria state that trade and product names must not suggest a drug or another product, or effects beyond a cosmetic. Examples of unacceptable words include CURE, MED, THERAPY, ANTISEPTIC, SLIMMING, BUST UP and STOP HAIR FALL, and a registered trademark is no exception. Check names before designing packaging; this is a common problem when overseas brand names are carried over unchanged.
Step 6: make the label match the notification
The Cosmetic Committee notification on cosmetic labelling B.E. 2562 (2019) requires, among other items, the cosmetic name and trade name, type, all ingredients in descending order, directions, manufacturer or importer name and address and country of manufacture, net quantity, batch number, month and year of manufacture, warnings where applicable, and the notification number. The label must be in Thai; imported cosmetics may add the Thai label within 30 days of customs release.
See every item with examples in Thai cosmetic labelling requirements, and check drafts with the label checker or the foreign-to-Thai label tool.
After notification: duties and how to renew cosmetic notification Thailand
The receipt is not the end. The notifier has continuing duties under the Cosmetic Act and related notifications:
- Make or import exactly as notified. Otherwise the authority may order suspension or correction, and may revoke the receipt.
- Follow the premises criteria, adverse reaction reporting and record keeping.
- Renew: the receipt is valid for three years; file form JK.2 within 180 days before expiry. If it has expired by no more than one month, renewal with a request for leniency is possible, subject to a daily penalty.
- Amend details on form JK.4.
- Replace a damaged or lost receipt on form JK.6 within 15 days of learning of it.
Manufacturing or importing without notification carries imprisonment and fines under the Cosmetic Act, so do not start selling before the receipt is issued.
Pre-filing checklist
- The product passes the five-point cosmetic test.
- No banned substances, restricted substances within limits, INCI names used.
- The applicant is eligible (Thai national aged 20 or over, or a Thai-registered company).
- Manufacturing or import and storage sites meet the criteria, with signage.
- Documents complete, including a company certificate under 6 months old and the brand owner's authorisation for imports.
- The product name has no words implying effects beyond a cosmetic.
- The draft label meets the 2019 notification.
For a team to manage notification end to end, from formula screening to receipt, see our registration and notification service, or ask initial questions in the RA Advisor.
Frequently asked questions
Can a foreign brand notify cosmetics in Thailand itself?
No. The applicant must be a Thai national aged 20 or over, or a company registered in Thailand. A foreign brand needs a Thai importer as notifier, with an authorisation from the brand owner or manufacturer.
Where is the notification filed?
Form JK.1 is filed at the Thai FDA, at the provincial public health office where the business is located, or through the Thai FDA online system.
How long is a Thai cosmetic notification valid?
Three years from issue. Renew on form JK.2 within 180 days before expiry.
Do export-only cosmetics need notification?
Yes. The Cosmetic Act requires notification for manufacture to a buyer's export specification, and such products may not be sold in Thailand.
Can a cream be named Therapy or Slimming?
No. The notification criteria prohibit names implying a drug or effects beyond a cosmetic, and a registered trademark is no exception.
Sources
- Cosmetic Act B.E. 2558 (2015) · Open source · Search our archive
- MOPH notification on cosmetic notification, receipts, renewal, amendment and replacement B.E. 2561 (2018) · Open source · Search our archive
- Cosmetic notification criteria (revised 2021) · Open source · Search our archive
- MOPH notification on criteria, methods and conditions for manufacturing or importing cosmetics B.E. 2561 (2018) · Open source · Search our archive
- Cosmetic Committee notification on cosmetic labelling B.E. 2562 (2019) · Open source · Search our archive
- Explanatory note on the cosmetic labelling notification · 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.