Thailand Updated Sunscreen Cosmetics Regulations

Zinc oxide nanoparticles and titanium dioxide nanoparticles are subject to usage restrictions when applied as UV filters in cosmetics. Sunscreen cosmetics must be labeled with specific warning information in Thai language.

According to the Thailand Food and Drug Administration ^[1], the Cosmetic Act B.E. 2015 was updated several times in the first half of 2019.

Usage restrictions on UV filters

In February, Thailand Ministry of Public Health (MOPH) issued a notification detailing restriction on the use of 2 permitted UV filters—zinc oxide and titanium dioxide—in the form of nanoparticles in cosmetics.

⭐The two substances are subject to the same maximum concentration of 25% and the same ban on the applications that may lead to exposure of the end-user's lungs by inhalation, but differ in the restrictions on the detailed specifications of nanoparticles.

Zinc Oxide (nano)

Titanium Dioxide (nano)

Purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total;
Median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm;
Water solubility < 50 mg/L

Coating materials can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behavior and/or effects.

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 can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behavior and/or effects,
Photocatalytic activity ≤ 10 % compared to corresponding non-coated or nondoped reference;
Nanoparticles are photostable in the final formulation.

MOPH’s restrictions on the above two ingredients are in line with part of the updates to the list of permitted UV filters under ASEAN Cosmetic Directive as adopted in the 26^th ASEAN Cosmetic Committee ^[2], and have officially taken effect as of March 30. All imported cosmetic stakeholders in Thailand are required to comply with the notification.

New labeling requirements for sunscreens

In the meantime, Thailand cosmetic committee modified the labeling requirements of sunscreen cosmetics, indicating that products with the addition of UV filters listed in the MOPH’s notification ^[3] must print specific warning statements in Thai on the label. The warning information includes:

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;

Significantly, specific labeling instructions are required for cosmetics containing oxybenzone. If the concentration of the substance is equal to or greater than 0.5%, the label must disclose the ingredient as a sunscreen agent. But the information of the ingredient shall not be specified if it is only used as a stability agent and the concentration is below 0.5%.

The new labeling requirements also came into force on March 30. Products marketed with old labels before March 30 can continue to be sold but are required to update their labels prior to March 30, 2020.