Thailand Introduces New Rules for Cosmetics Containing Titanium Dioxide

On April 21, 2025, the Thai Food and Drug Administration (Thai FDA) announced new regulatory requirements for cosmetic products that contain Titanium Dioxide in powder form and pose an inhalation risk. The move is part of Thailand’s broader efforts to enhance consumer safety amid increasing concern over nano-sized particles used in cosmetic formulations.

Background

These new requirements are based on three Ministerial Notifications issued by Thailand’s Ministry of Public Health, which came into effect on November 19, 2024. The notifications revise the regulatory requirements of Titanium Dioxide as a restricted ingredient, a permitted colorant, and a permitted sunscreen agent. 

Cosmetic products notified before the effective date are granted a 180-day grace period, until May 18, 2025, to achieve full compliance.

Scope of New Rules

The new rules apply to cosmetic products that contain Titanium Dioxide in powder form containing 1% or more of particles with an aerodynamic diameter of ≤10 microns and presents a potential inhalation risk. This specifically includes products in the following physical forms:

• Powder/Dust/Flake-form cosmetics

• Pressurized (aerosol) spray products

• Non-pressurized spray products

Manufacturers and importers of such products must:

• Identify and verify the form of Titanium Dioxide used in their cosmetic formulations,

• Ensure the product complies with all applicable conditions specified in the three notifications,

• Retain relevant ingredient information in the Product Information File (PIF) for regulatory inspection.

Mandatory Certification

To facilitate the notification process, the Thai FDA issued a Certification Letter for Cosmetics Containing Titanium Dioxide, with the template available on the Thai FDA’s official website. This document confirms whether the Titanium Dioxide used meets regulatory particle size limits and verifies compliance with the three Ministerial Notifications.

Manufacturers may use this certification either to directly verify the titanium dioxide used in their products or as a reference when preparing their own declaration. The certification is required only for the specified high-risk inhalable products and must be attached to the product notification application.

Starting April 10, 2025, all new cosmetic notifications for such products must accompanied by the certification and the relevant ingredient information must be included in the PIF. For products that received notification approval before April 10, 2025, it is sufficient to keep the relevant information in the PIF without resubmitting the certification.