Thailand Updates Titanium Dioxide Regulations for Cosmetics

On November 18, 2024, the Thai Food and Drug Administration (Thai FDA) officially approved amendments to regulations governing the use of Titanium Dioxide in cosmetics. These updates, which reflect changes introduced in the ASEAN Cosmetic Directive (ACD) during the 36^th ASEAN Cosmetic Scientific Body (ACSB) meeting, aim to align Thailand's cosmetics regulations with regional standards.

The amendments took effect on November 19, 2024. A 180-day grace period has been provided for cosmetic stakeholders to comply with ingredient-related updates if their products containing the affected Titanium Dioxide ingredients were already manufactured, imported, or sold before the announcement. However, no grace period has been granted for the labeling requirements updates.

Key Changes

1. Additions to the “List of Restricted Ingredients”

Two new entries for Titanium Dioxide ingredients have been added to the restricted ingredients list.¹ The “List of Warnings on Labels for Cosmetics Containing Restricted Ingredients” has also been updated to reflect these additions.² However, no specific labeling requirements are mandated for these newly added restricted ingredients.

Entry No.	Substance/Cas No.	Field of Application and/or Use	Maximum Authorized Concentration in the Ready-for-Use Preparation	Other Limitations and Requirements	Warnings on the Label
212a	Titanium Dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤10 µm Titanium Dioxide 13463-67-7 / 1317-70-0 / 1317-80-2	Face products in loose powder form	25%	Only the use of Titanium Dioxide in the pigmentary form is allowed.	-
		Hair aerosol spray products for general consumers	1.4%	Only the use of Titanium Dioxide in the pigmentary form is allowed.	-
		Hair aerosol spray products for professional use	1.1%	Only the use of Titanium Dioxide in the pigmentary form is allowed.	-
		Other products	-	Titanium Dioxide shall not be used in applications that may lead to exposure of the end-user’s lungs by inhalation.	-
212b	Titanium Dioxide, other than Entry 212a Titanium Dioxide 13463-67-7 / 1317-70-0 / 1317-80-2	All types of products		1. For use of this substance as a colorant in cosmetics, the conditions specified in the “List of Permitted Colorants” shall be followed. 2. For use of this substance as a sunscreen in cosmetics, the conditions specified in the “List of Permitted Sunscreen” shall be followed.	-

2. Condition Update for Titanium Dioxide as a Permitted Colorant

A new condition has been introduced for Titanium Dioxide in the “List of Permitted Colorants”.³

Entry No.	Substance/Cas No.	Colour Index (CI) No.	Color	Field of Application and/or Use				Other Limitations and Requirements
Entry No.	Substance/Cas No.	Colour Index (CI) No.	Color	1	2	3	4
146	Titanium Dioxide 13463-67-7	77891	White	√				For Titanium Dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤10 µm, the conditions specified in the “List of Restricted Ingredients” shall be followed.
Notes: Field 1 refers to all types of cosmetics. Field 2 refers to all types of cosmetics except for those used around the eyes. Field 3 refers to all types of cosmetics except for those in contact with mucous membranes. Field 4 refers to cosmetics that must be rinse-off products. “√” means allowed to be used in that type of cosmetics

3. Revisions to Titanium Dioxide as a Permitted Sunscreen

The existing "Entry 24 Titanium Dioxide, including as nanomaterial" in the “List of Permitted Sunscreens” has been split into two separate entries: "Entry 24 Titanium Dioxide" and "Entry 24a Titanium Dioxide (nano)". The use conditions for both entries have been modified accordingly.⁴

Comparison	Entry No.	Substance/CAS No.	Maximum Authorized Concentration in the Ready-for-Use Preparation (w/w)	Conditions
Before Revision	24	Titanium Dioxide, including as nanomaterial 13463-67-7 / 1317-70-0 / 1317-80-2	25% (These substances can be used alone or in combination with the caveat that the sum of the substances must not exceed 25%)	1. For ingredients in nano form, not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. 2. Only nanomaterials having the following characteristics are allowed: Purity ≥ 99% Rutile form, or rutile with up to 5% anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, Median particle size based on number size distribution ≥ 30 nm, Aspect ratio from 1 to 4.5 and volume specific surface area ≤ 460 m2 /cm3, Coating materials that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects can be used, Photocatalytic activity ≤ 10% compared with corresponding non-coated or non-doped reference, Nanoparticles are photostable in the final formulation. 3. For the use of this substance as a colorant in cosmetics, the conditions specified in the “List of Permitted Colorants” shall be followed.
After Revision	24	Titanium Dioxide 13463-67-7 / 1317-70-0 / 1317-80-2	25% (can be used alone or mixed with Titanium Dioxide (nano), provided that the sum shall not exceed 25%)	1. For Titanium Dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤10 µm, the conditions specified in the “List of Restricted Ingredients” shall be followed. 2. For use of this substance as a colorant in cosmetics, the conditions specified in the “List of Permitted Colorants” shall be followed.
After Revision	24a	Titanium Dioxide (nano) 13463-67-7 / 1317-70-0 / 1317-80-2	25% (can be used alone or mixed with Titanium Dioxide (nano), provided that the sum shall not exceed 25%)	1. Titanium Dioxide (nano) shall not be used in applications that may lead to exposure of the end-user’s lungs by inhalation. 2. Only nanomaterials having the following characteristics are allowed: Purity ≥ 99% Rutile form, or rutile with up to 5% anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, Median particle size based on number size distribution ≥ 30 nm, Aspect ratio from 1 to 4.5 and volume specific surface area ≤ 460 m2 /cm3, Coating materials that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects can be used, Photocatalytic activity ≤ 10% compared with corresponding non-coated or non-doped reference, Nanoparticles are photostable in the final formulation.

Additionally, the “List of Warnings on Labels for Cosmetics Containing Permitted Sunscreens” has been revised to align with these changes.⁵ Specifically:

The substance name under Entry 24 has been updated.
Entry 24a has been added, with its labeling requirements mirroring those for Entry 24.

Comparison	Entry No.	Substance/CAS No.	Warnings on the Label
Before Revision	24	Titanium Dioxide, including as nanomaterial 13463-67-7 / 1317-70-0 / 1317-80-2	The use of sunscreens is one way to reduce the dangers from sun exposure; Please read the usage instructions carefully and strictly follow them; Discontinue use and consult a doctor or pharmacist if any adverse reactions occur.
After Revision	24	Titanium Dioxide 13463-67-7 / 1317-70-0 / 1317-80-2	The use of sunscreens is one way to reduce the dangers from sun exposure; Please read the usage instructions carefully and strictly follow them; Discontinue use and consult a doctor or pharmacist if any adverse reactions occur.
After Revision	24a	Titanium Dioxide (nano) 13463-67-7 / 1317-70-0 / 1317-80-2	The use of sunscreens is one way to reduce the dangers from sun exposure; Please read the usage instructions carefully and strictly follow them; Discontinue use and consult a doctor or pharmacist if any adverse reactions occur.