Thailand Proposes Amendments to Titanium Dioxide Requirements in Cosmetics

On April 19, 2024, the Thai Food and Drug Administration (Thai FDA) launched a public consultation, seeking input on proposed amendments to the regulations concerning Titanium Dioxide usage in cosmetics. These revisions largely mirror updates made to the ASEAN Cosmetic Directive (ACD) during the 36^th ASEAN Cosmetic Scientific Body (ACSB) meeting.

The consultation period will conclude on May 3, 2024. Stakeholders are encouraged to provide feedback through the Thai FDA’s consultation page. If approved, the amendments will take effect upon publication in the government gazette. A grace period of 180 days will be granted to cosmetic stakeholders who have already manufactured, imported, or sold products containing affected Titanium Dioxide ingredients prior to the official announcement.

Details of the proposed revisions are outlined as follows, with additions or revisions highlighted in red:

1. Adding Two Entries of Titanium Dioxide Ingredients to the “List of 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.	-

In accordance with the updated restricted ingredient list, revisions will also be made to the “List of Warnings on Labels for Cosmetics Containing Restricted Ingredients” to include the above two entries of Titanium Dioxide ingredients. However, no specific labeling requirements will be mandated for them.

2. Introducing a Requirement for Using Titanium Dioxide as a Colorant to the “List of Permitted Colorants”

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. Revising the Use Requirements of Titanium Dioxide as a Permitted Sunscreen in the “List of Permitted Sunscreens”

The current "Entry 24 Titanium Dioxide, including as nanomaterial" in the “List of Permitted Sunscreens” will be split into two separate entries: "Entry 24 Titanium Dioxide" and "Entry 24a Titanium Dioxide (nano)". Their use conditions will be modified accordingly.

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), but 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), but 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.

Furthermore, to align with the revised list of permitted sunscreens, corresponding adjustments will be made to the “List of Warnings on Labels for Cosmetics Containing Permitted Sunscreens.” This includes revising the substance name in Entry 24 and adding Entry 24a. It is important to note that the labeling requirements for Entry 24 will remain unchanged, and those for Entry 24a will mirror.

Amended Type

Entry No.

Substance/CAS No.

Warnings on the Label

Revision

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.

Addition

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.