×

Access all guidelines and regulatory updates on

QuriousRI
×

Access all guidelines and regulatory updates on

QuriousRI

Artixio

Cosmetics Regulations in Thailand: Notification, Requirements & Costs

Cosmetics Regulations in Thailand Requirements

Cosmetic products entering Thailand, particularly imported skincare, personal care, and formulations of beauty products, tend to be delayed or held at the port of entry. For regulatory teams and product owners, it is not the system that is problematic, but when compliance is inspected. Thailand operates under a pre-market notification system. Products proceed very fast, only to be detected later during audits or inspections.

Teams end up experiencing issues when products are already in transit or about to be launched. Misclassification through claims, incomplete formulation disclosure, labeling mistakes or lack of a Thai entity is usually detected during import inspections or post-market inspection. This results in rework, shipment delays, or product recall.

Regulatory Authority for Cosmetics in Thailand

Cosmetics regulations in Thailand are centralized in law and implemented through various channels.

Thai FDA (TFDA) – Core Authority

  • Operates under the Ministry of Public Health
  • Handles product notification, compliance, and enforcement
  • No pre-market approval; TFDA does not validate products before entry

Legal Framework

The cosmetics in Thailand are governed by Cosmetics Act B.E. 2558 (2015), which defines a cosmetic and establishes the safety and labeling and company liability requirements. The detailed rules are issued by the Ministry of Public Health and are enforced by the Thai FDA.

Responsibility Model

  • Regulation is at the product level (notification)
  • Accountability is at the company level (notifier)
  • Only a Thai entity can hold the notification

Operational Structure

  • Submissions via:
    • TFDA (central)
    • Provincial Public Health Offices
    • Online system
  • Leads to variation in processing and enforcement

Classification of Cosmetics in Thailand

Classification is based on legal definition and product claims, not marketing categories.

Under the Cosmetics Act B.E. 2558 (2015), a cosmetic is any product applied to the outer body to clean, beautify, protect, or preserve condition, but not to influence body structure or functionality. It is not considered cosmetic when it surpasses this.

TFDA evaluates classification based on:

  • Intended use
  • Claims
  • Ingredients

All must remain within cosmetic scope.

Thailand follows the ASEAN Cosmetic Directive (ACD). It controls ingredient lists, definitions, and claims. But local interpretation may still lead to reclassification, especially for claims and labeling.

Step-by-step Cosmetic Approval Process in Thailand

The Thailand cosmetic registration process below shows how you can handle registration to avoid rework.

These are steps defined by the Thai FDA for cosmetic approval registration:

Step 1: Submit notification

File product details with TFDA (via e-submission system or authorized channels) before import or manufacture.

Step 2: Receive notification number

Issued upon submission; required before placing the product on the market.

Step 3: Import/manufacture and sell

The product can enter the market once notification is obtained, subject to import requirements.

Step 4: Post-market compliance

The TFDA may check the product safety and the labels on the products after they enter the market.

Operational Steps (What teams must do before submission)

At an operational level, these steps can avoid failures.

Step 1: Appoint a Thai entity

Only a local importer/manufacturer can hold the notification.

Step 2: Align formulation with ASEAN/Thai rules

Check ingredient restrictions, limits, and usage conditions.

Step 3: Validate claims against classification rules

Ensure claims do not push the product outside the cosmetic scope.

Step 4: Finalize Thai-compliant labeling

Labels must meet local language and content requirements before import.

Step 5: Prepare business and facility details

Required as part of the notification submission.

Documents Required For Thai FDA Cosmetic Notification

TFDA needs product and company information after submission; evidence has to be available to audit.

  • Product

Include product name, type, intended use, and complete formulation with INCI names, concentrations, and functions of the ingredients.

  • Company

Include information about the Thai notifier and information about manufacturing, import, and storage facilities.

  • Legal

Provide a Letter of Authorization for foreign brands and trademark documentation, when necessary.

  • Compliance

Incorporate the GMP certificate of the production facility and final label artwork (inner and outer packaging).

  • Supporting

Keep safety data and claims substantiation to be reviewed and audited by the regulatory authorities.

Gaps are typically flagged during audits, not at submission.

Thailand Cosmetic Notification System/Registration

Companies are required to inform TFDA prior to the manufacture or importation of a cosmetic product.

  • Submission is done through the TFDA e-submission system (SKYNET) or via FDA/provincial offices.
  • Submission is done via the TFDA e-submission system (SKYNET) or authorized FDA/provincial channels.
  • Once submitted, a notification number is issued upon submission. This confirms filing, not product validation.
  • Compliance is checked post-market through audits and inspections, not before launch.
  • Notification validity is 3 years, after which renewal is required.

Cosmetics Regulatory Guidelines in Thailand

Thailand’s regulatory model is built on company accountability. The notifier (importer or manufacturer) is responsible for ensuring:

  • Product safety
  • Ingredient compliance
  • Accurate labeling
  • Substantiated claims

Thailand is compliant with the ASEAN Cosmetic Directive (ACD), which standardizes:

  • Ingredient restrictions (prohibited, restricted, permitted lists)
  • Labeling requirements
  • Claims guidelines
  • Safety assessment and documentation (Product Information File)

Regulatory updates in Thailand are typically issued through alignment with ASEAN changes, for example, updates to prohibited ingredient lists or technical standards.

Thailand Cosmetic Labeling Requirements

Labeling should follow the compliance rules before sale, as it is one of the major reasons for delay.

  • Language: Thai, legible and clear.
  • Should contain: product name/function, instructions, complete list of ingredients, importer/manufacturer information, notification number.
  • Claims: should be factual, substantiated, and not medical.
  • Format: readable, correctly placed, all required info visible

Non-compliance is frequently identified at import or post-market.

Ingredients Restrictions & Compliance

Under the ASEAN Cosmetic Directive (ACD), the ingredient restrictions include:

Key controls:

  • Prohibited ingredients – cannot be used under any condition
  • Restricted ingredients – allowed with limits (concentration, usage conditions)
  • Permitted lists – colorants, preservatives, UV filters

These lists are enforced at the time of notification and during audits.

Safety requirement:

  • Companies must ensure product safety based on:
    • Ingredient profile
    • Intended use and exposure
  • Supporting safety data must be available for inspection (Product Information File concept under ASEAN)

High-risk triggers:

  • Whitening ingredients
  • Preservatives beyond limits
  • SPF/UV claims

Even if a product is approved in the US/EU, it may require reformulation to meet ASEAN limits or usage conditions.

Import Requirements for Cosmetics in Thailand

Import is allowed only after notification.

  • Requirements: Thai legal entity, registered import facility
  • Per shipment: customs declaration, invoice, product details, labeling

Products are inspected at entry. Any mismatch with notification can delay clearance.

GMP (Good Manufacturing Practice) Requirements

GMP compliance is mandatory for cosmetic manufacturing.

Requirements:

  • Manufacturing sites must comply with ASEAN GMP standards
  • A GMP certificate is required as part of the documentation

Facilities under scope:

  • Manufacturing site
  • Storage/warehouse (for importers)

Regulatory expectation:

  • Facilities may be inspected or required to demonstrate compliance
  • Documentation must be available at submission and during audits

Cost of Cosmetic Registration in Thailand

Thailand’s cost structure is straightforward at the regulatory level, but increases with execution gaps.

Fee Component Amount (THB)
Notification application fee (per product) 100
Notification certificate / receipt (per formula) 900
Notification certificate (community enterprises only) 500
Notification receipt (manufacture/import/subcontract – industry-referenced consolidated fee) 5,000
Replacement notification receipt 1,000
Modification / amendment of notification 500

Post-Market Surveillance & Compliance

TFDA enforces compliance after market entry through inspections, testing, and document review.

The notifier is responsible for:

  • Product safety
  • Claims accuracy
  • Maintaining supporting documentation

Non-compliance can lead to product removal, recall, or suspension. Labels and claims must remain consistent with the notification.

Conclusion

The regulatory risk is addressed via classification, formulation, labeling, local representation, and post-market compliance. Gaps in execution, rather than the process, cause most delays and enforcement actions.

If you want to sell your cosmetics in Thailand, Artixio can help you with that. We do all the paperwork, offering Cosmetics regulatory affairs services in Thailand, and make sure your cosmetics follow the rules. We help you with classification, sending in the forms, labeling your products correctly, and making sure your products are compliant. Our team at Artixio makes sure your cosmetics meet the rules of the TFDA and ASEAN before they go on sale. If you need help with this, you can email us at info@artixio.com.

FAQs

1. Do cosmetics have to be registered by the Thai FDA to sell them?

No. Thailand adheres to the notification system. Before importing or producing, you must notify TFDA, although there is no pre-market approval.

2. Is it possible to file a cosmetic notification by a foreign company?

No. The notifier should be a manufacturer, importer of a good, or a legal entity based in Thailand.

3. What is the duration of a cosmetic notification?

A notification can last up to 3 years, and you must renew a notification before it expires.

4. What is done once a company has made its notification? Is the product reviewed by TFDA?

Yes, but once it has entered the market. To check compliance, TFDA checks, inspects documents, and monitors the market. It does not have complete verification during submission.

5. How long does registration of cosmetics take in Thailand?

This normally takes 4-8 weeks based on the labeling, paperwork, etc.

Get in touch

×