Session 1: Confirming Product Classification as a Cosmetic
1.1 Legal Definition of a Cosmetic under Thai Law
The Cosmetics Act B.E. 2558 (2015) defines a cosmetic product as any substance or formulation intended to be applied externally to the human body—including the teeth and oral mucosa—for the purpose of cleaning, beautifying, altering appearance, reducing body odour, protecting, or maintaining the body in good condition, and that does not function as an ornament or garment. The definition also encompasses substances used as ingredients in the manufacture of cosmetics, as well as any other products designated as cosmetics by ministerial proclamation.
1.2 Product Categorisation Methodology
Operators should verify classification by cross-referencing the product’s intended function and composition against the illustrative product examples published on the Thai Food and Drug Administration (TFDA) website under the ‘What are Cosmetics?’ section. Reference categories include, among others, moisturising creams, soaps, toothpastes, lipsticks, hair dye products, and tooth-whitening formulations.
Concurrent reference to the ASEAN Cosmetic Directive (ACD)—including its Illustrative Product List, Claim Guideline, and Labelling Requirements—is recommended to ensure that the product’s category and intended claim scope are consistent with the regional regulatory framework adopted across ASEAN member states.
| Critical Classification Warning: Any product whose intended function or communicated benefit could be interpreted as affecting the structure or physiological functioning of the body, or as providing a therapeutic or medicinal effect, is likely to fall outside the cosmetic classification. Such products would instead be subject to the regulatory requirements applicable to pharmaceutical drugs or medical devices, which entail substantially more rigorous pre-market approval procedures. |
Session 2: Operator and Facility Registration
2.1 e-Submission Account Setup and Cosmetic Notification Procedure
Any manufacturer or importer intending to market cosmetic products in Thailand is legally required to submit a cosmetic notification (product detail notification) to the TFDA prior to commencing manufacture or importation for sale. Submissions may be made electronically via the TFDA’s e-Submission system, or in person at TFDA headquarters or a Provincial Public Health Office.
Upon successful notification, the TFDA issues a Cosmetic Notification Receipt valid for three years. Renewal applications must be submitted within six months prior to the expiry date. The e-Submission account activation requires identity verification for the operator or authorised representative, using credentials supported by the TFDA system.
2.2 Facility Approval: Manufacturing, Import, and Storage Premises
The TFDA requires that all premises used for cosmetic manufacturing, importation, or storage be formally registered and approved as designated notification facilities. The registered address of the facility must appear in the company’s certificate of incorporation issued by the Department of Business Development (as either the registered head office or a registered branch). Certain flexibility exists regarding the registration of warehousing facilities, subject to the specific TFDA guidelines applicable to each category of storage arrangement.
When submitting a product notification, the operator must record comprehensive information regarding the responsible operator, the manufacturing and import facilities, storage premises, and full formulation details—including ingredient compositions, concentrations, and conditions of use—on the prescribed notification form (Form Jor Kor / Form JK) in accordance with applicable TFDA notifications.
Session 3: Ingredient Compliance — Prohibited, Restricted, and Permitted Substances
Thailand adopts the ASEAN Cosmetic Directive (ACD) as the uniform regional standard governing cosmetic ingredient regulation across all ASEAN member states. Ingredient compliance is governed by the substance lists contained in the ACD’s annexes, each addressing a distinct category of regulatory control.
| ASEAN Cosmetic Directive (ACD) — Relevant Annexes for Ingredient Compliance | |
| Annex II | Prohibited Substances — substances that may not be used in cosmetic products under any circumstances |
| Annex III | Restricted Substances — substances permissible only under specified conditions and concentration limits |
| Annex IV | Permitted Colouring Agents — approved list of colorants authorised for use in cosmetics |
| Annex VI | Permitted Preservatives — approved list of preservative substances and their permissible concentrations |
| Annex VII | Permitted UV Filters — approved list of ultraviolet filter substances and applicable use conditions |
The ACD annexes are subject to regular revision, typically updated at least twice annually following meetings of the ASEAN Cosmetic Committee (ACC) and the ASEAN Cosmetic Scientific Body (ACSB). A notable update in December 2025 amended Annexes II, III, and VII, and a comprehensive annex release was published on 2 July 2025. Operators must verify that their formulations comply with the most current version of all relevant annexes prior to finalising any product formulation. Reliance on superseded annex versions constitutes a compliance risk.
Session 4: Product Naming Rules
4.1 General Prohibitions Applicable to Product Names
Cosmetic trade names and product names must not be misleading to consumers, must not imply therapeutic or pharmacological properties, and must not suggest effects that fall outside the legally defined scope of cosmetics. These requirements are consistent with both the TFDA’s advertising and labelling standards and the broader ACD Claim Guideline framework.
Where a product formulation incorporates a nano-material ingredient, the TFDA requires that the suffix ‘(nano)’ be appended to the name of that ingredient as it appears on the product label. Such designations must not be used as a basis for making exaggerated or unsubstantiated efficacy claims within the product name itself.
4.2 Updated TFDA Guidelines on Prohibited Words in Product Names (2025)
In 2025, the TFDA published revised guidelines on prohibited words for use in cosmetic trade names and product names (updated 22 August 2025, published 12 November 2025). These guidelines establish standardised criteria for evaluating proposed product names against categories of prohibited terminology, with the objective of reducing interpretive ambiguity and improving consistency in TFDA review decisions. Provision is made for operators to submit a formal exemption application in respect of certain word categories where justified circumstances exist.
Operators are strongly advised to review these guidelines in full before finalising any product name intended for market registration, as non-compliance at the naming stage may result in rejection of the notification application and consequent delays to product launch.
Session 5: Labelling Requirements
5.1 Mandatory Label Elements under the Cosmetic Committee Notification B.E. 2562 (2019)
All cosmetic product labels must be clearly affixed or printed and fully legible. The following information is mandatorily required on every cosmetic label:
| Mandatory Label Requirements — Cosmetic Committee Notification B.E. 2562 (2019) | |
| 1 | Product name / trade name (must appear in a font size larger than all other text) |
| 2 | Product category / type |
| 3 | Full ingredient list in INCI nomenclature, in descending order of concentration (colorants and substances at <1% may be listed at the end) |
| 4 | Directions for use |
| 5 | Name and address of manufacturer (for domestically produced goods) OR name and address of importer plus name of manufacturer and country of manufacture (for imported goods) |
| 6 | Net quantity |
| 7 | Batch / lot number |
| 8 | Month and year of manufacture |
| 9 | Month and year of expiry (required where shelf life is less than 30 months or where the product appears on the specified annex) |
| 10 | Mandatory warnings, where prescribed |
| 11 | Cosmetic Notification Number issued by the TFDA |
5.2 Language Requirements and Exemptions for Small Packaging
Thai language is the primary language requirement for cosmetic labels in Thailand. Additional languages may be displayed alongside Thai text. Ingredient names may be rendered in Thai transliteration, English, or INCI nomenclature.
For primary packaging with a surface area of less than 20 cm², certain mandatory label elements may be presented in abbreviated form on the container itself, provided that a supplementary package insert or leaflet containing the full required information is included with the product. The specific minimum requirements for small-format labels are prescribed in the applicable TFDA notification.
Session 6: Advertising Claims, Product Information File, and Adverse Event Reporting
6.1 Permissible Claims and Advertising Standards
All claims made on product labels and in advertising materials must be truthful, substantiated by appropriate scientific evidence, and confined to the scope of effects attributable to cosmetic products. Claims that could be construed as implying a therapeutic, medicinal, or pharmacological mode of action are prohibited. The applicable standards are established by the ACD Claim Guideline and reinforced by TFDA-issued advertising and labelling notifications.
Thailand does not impose a mandatory pre-market advertising approval requirement for cosmetic products. However, operators who are uncertain as to whether a proposed claim falls within the permissible scope may submit a formal request for a pre-opinion to the TFDA. Where the TFDA determines that published advertising is misleading, exaggerated, or non-compliant, it holds authority to order amendment, suspension, or withdrawal of the advertising, with penalties applicable under the Cosmetics Act.
6.2 Product Information File (PIF) — Mandatory Compilation and Retention
Every notified cosmetic product must be supported by a Product Information File (PIF) compiled in accordance with the ASEAN Cosmetic Directive guidelines and the TFDA’s domestic guidance. The PIF must be accessible at the address stated on the product label at all times, to facilitate post-market surveillance inspections. The PIF is structured into four principal parts:
| Product Information File (PIF) — Four-Part Structure | |
| Part I — Administrative and Product Summary | Includes the product formula, label specimens, manufacturing method, summary of adverse event data, and supporting evidence for claims. |
| Part II — Raw Material Quality and Safety | Comprises specifications and Safety Data Sheets (SDS) for all raw material ingredients. |
| Part III — Finished Product Quality | Includes the master formula, finished product specification, stability study data, and microbiological limits. |
| Part IV — Safety Assessment and Scientific Evidence | Contains the cosmetic product safety assessment report and all scientific evidence substantiating the product’s efficacy and safety claims. |
6.3 Adverse Event Reporting Obligations
Holders of cosmetic notification receipts are required to maintain an internal system for monitoring adverse events (AEs) associated with their products and to report such events through the TFDA’s Health Product Vigilance Centre (HPVC) system. Online adverse event reporting channels are available separately for operators and healthcare professionals, and for end consumers. Timely and accurate adverse event reporting is both a regulatory obligation and a critical component of post-market safety surveillance.
Practical Compliance Workflow
The following six-step workflow summarises the mandatory compliance sequence for operators seeking to bring a cosmetic product to market in Thailand:
| Six-Step Cosmetic Compliance Workflow | |
| Step 1 — Confirm Cosmetic Classification | Verify that the product meets the legal definition of a cosmetic under the Cosmetics Act B.E. 2558 and the ACD. Cross-check against TFDA’s illustrative product examples and the ACD Claim Guideline to confirm the intended claims fall within cosmetic scope. |
| Step 2 — Register Premises and Open e-Submission Account | Ensure that the manufacturing, import, and storage facilities are approved in accordance with TFDA requirements and that the company address is correctly registered with the Department of Business Development. Activate the TFDA e-Submission account with verified operator/representative credentials. |
| Step 3 — Conduct Ingredient Compliance Review | Screen the full formulation against the current versions of ACD Annexes II, III, IV, VI, and VII. Amend the formulation or adjust ingredient concentrations as necessary to achieve full compliance with all applicable restrictions and permissions. |
| Step 4 — Submit Cosmetic Notification | File the product detail notification via the e-Submission system or at the TFDA/Provincial Health Office. Upon completion, obtain the Cosmetic Notification Receipt, which is valid for three years. |
| Step 5 — Prepare Compliant Thai-Language Label | Design the final product label incorporating all mandatory elements, including the Cosmetic Notification Number. Ensure full compliance with the Cosmetic Committee Notification B.E. 2562 requirements on language, format, and content. |
| Step 6 — Compile the PIF and Establish AE Monitoring | Assemble the complete Product Information File in accordance with ASEAN/TFDA guidelines and ensure it is accessible at the registered address. Implement an internal adverse event monitoring system and configure reporting channels through the TFDA HPVC platform. |
Appendix: Principal Reference Sources
The following authoritative sources should be consulted directly for operational implementation, as regulatory requirements are subject to ongoing revision:
- TFDA Cosmetics Entrepreneur Portal: e-Submission procedures, notification application requirements, notification receipt validity, and Thai labelling standards. Available at en.fda.moph.go.th.
- Cosmetics Act B.E. 2558 (2015): Primary legislation governing the definition, classification, and regulatory framework for cosmetics in Thailand. English translation available at en.fda.moph.go.th.
- Cosmetic Committee Notification on Labelling B.E. 2562 (2019): Detailed mandatory labelling requirements. Available at en.fda.moph.go.th.
- ASEAN Cosmetic Directive (ACD) and Annexes: Comprehensive regional standard governing ingredient permissions, restrictions, and prohibitions, updated December 2025. Primary reference: hsa.gov.sg and asean.org.
- ACD Product Information File (PIF) Guidelines: ASEAN-level guidance on PIF structure and content requirements, supplemented by TFDA’s domestic PIF guidance.
- TFDA Health Product Vigilance Centre (HPVC) — AE Online Reporting: Platform for post-market adverse event reporting by operators, healthcare professionals, and consumers. Available at hpvcthai.fda.moph.go.th.
- TFDA Updated Guidelines on Prohibited Words in Cosmetic Names (22 August 2025): Guidance document on permissible and prohibited terminology in cosmetic trade names and product names, published 12 November 2025.
Compiled from official TFDA, ASEAN Cosmetic Committee, and industry practitioner sources. Regulatory requirements are subject to ongoing revision. Operators are advised to verify all current requirements directly with the TFDA prior to each product notification submission.
