Thailand Cosmetic Registration (Thai FDA – Cosmetics Act B.E. 2558)

1. Regulatory Authority & Framework

Cosmetics in Thailand are regulated under:

• Cosmetics Act B.E. 2558 (2015)
• Ministerial Notifications on Cosmetics
• ASEAN Cosmetic Directive (ACD) – fully adopted
• Thai FDA – Bureau of Cosmetics and Hazardous Substances Control

Thailand follows the ACD model using a notification system, not pre-approval.

2. Classification of Cosmetics (Thailand)

Thailand follows ASEAN & ACD definitions:

A cosmetic is a product applied to external parts of the body (skin, hair, nails, lips, external genitalia) or teeth/mucosa for cleansing, beautifying, fragrance, altering appearance, or protecting/maintaining condition.

Borderline products may be considered drugs, medical devices, or hazardous substances if claims exceed cosmetic scope (e.g., acne cure, melasma treatment, hair growth).

3. Types of Cosmetics Under Thai FDA

Thailand uses three regulatory categories:

1. RISK-CONTROLLED COSMETICS – Require Notification
2. SPECIAL–CONTROLLED COSMETICS – Require specific standards, warnings
3. GENERAL COSMETICS – Subject only to general provisions, but still must notify before market entry

All cosmetics require online notification.

4. Registration Type – Cosmetic Notification (Thai FDA Notification Number)

Thailand requires a Cosmetic Notification (not approval).

Output:

• Notification Number (to be printed on label)
• Validity: Unlimited, unless product is changed or regulations updated

Notification must be completed by a local Thai company (Responsible Person).

5. Responsible Person (RP) Requirement

Foreign manufacturers cannot notify directly.

A Thai Responsible Person (importer/manufacturer/distributor) must:

• Submit the notification through the Thai FDA e-Cosmetic Portal
• Ensure compliance with ACD
• Maintain PIF (Product Information File)
• Handle PMS (post-marketing surveillance)
• Manage recalls, adverse events, and inspections
• Ensure correct labeling (Thai language required)

6. Cosmetic Notification Dossier (Thai FDA e-portal)

Required Documents / Data

1. Online Notification Form via Thai FDA system
2. Product Information File (PIF)
   • Part I: Administrative documents
   • Part II: Quality & manufacturing information
   • Part III: Safety assessment
   • Part IV: GMP (ISO 22716 preferred)
3. Full Ingredient List (INCI)
4. Formula % breakdown
5. Label Artwork (Thai language required)
6. Company registration & RP authorization
7. Free Sale Certificate (CFS) for imported products
   • Not always required for low-risk items
   • Must be legalized if required by FDA
8. Documentation supporting claims (if applicable)

Note: Submission is typically instant, but FDA may subsequently audit or request clarifications.

7. Ingredient Rules (ASEAN Cosmetic Directive)

Thailand fully applies ACD Annexes:

• Annex II – Prohibited ingredients
• Annex III – Restricted ingredients
• Annex IV – Colorants allowed
• Annex VI – UV filters
• Annex VII – Preservatives

Key restrictions:

• Hydroquinone, steroids, tretinoin → prohibited
• Mercury → zero tolerance
• Salicylic acid, AHA, hair dye ingredients → restricted & require warnings
• Sunscreen UV filters must be on the Annex VI list

8. Labeling Requirements

Labeling must comply with Thai FDA rules and ACD.

Mandatory on Outer & Inner Packaging:

• Product name & function
• Ingredient list (INCI)
• Net content
• Batch/lot number
• Manufacture & expiry date
• Country of manufacture
• Name & address of Thai Responsible Person
• Thai language labeling (essential)
• Warnings for restricted ingredients (AHA, hair dye, etc.)
• Notification number (“เลขที่ใบรับแจ้ง”)

Sticker labels are accepted for imported products.

9. Fees & Timelines

Government Fee

• THB 1,000 per product (approx.)

Timeline

• Online submission: Instant
• Notification Number: issued immediately (subject to post-market review)
• Validity: No expiry, but must update if product changes

Thailand’s system is one of the fastest in ASEAN for cosmetics.

10. Post-Market Surveillance (PMS)

Thai FDA performs:

• Random inspections
• Laboratory testing
• Online monitoring of claims
• Spot checks at import and distribution
• Enforcement against illegal/unsafe cosmetics

RP obligations:

• Maintain PIF for at least 3 years after last batch marketed
• Report serious adverse events
• Manage recalls
• Maintain GMP and labeling compliance

11. Borderline Product Rules (Important)

Following types cannot be notified as cosmetics**:**

• Acne treatment (ingredients like benzoyl peroxide, high SA levels)
• Melasma/pigmentation treatment (“treat”, “cure” claims)
• Hair loss treatment / hair growth agents
• Antiseptic & disinfectant products
• Medicated shampoos (anti-dandruff)
• Skin-whitening with medicinal claims
• Anti-inflammatory, wound healing, scar treatment

These fall under drug or medical device regulations.

12. Consulting Notes for Your Portfolio

13. Advantages of Thailand Cosmetic Market

• Very fast entry (instant notification)
• Harmonized with ASEAN Cosmetic Directive
• Strong cosmetic consumption in retail & online markets
• Transparent regulatory system
• Bilingual labeling allowed (Thai must be present)