CI 77891

Titanium dioxide (airborne, unbound particles of respirable size) can cause cancer according to California Labor Code.

Source: PubChem

US FDA substance register · UNII 15FIX9V2JP · registered name TITANIUM DIOXIDE · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

CI 77891 is classed chemically as an inorganic colour (see also INCI: Titanium dioxide). It conforms to the formula

Restricted

Taiwan

Allowed UV filter

Taiwan · United Kingdom

Allowed colourant

Taiwan · United Kingdom

Source: ASEAN Cosmetic Directive · EU Cosmetics Regulation · MFDS (Korea) cosmetic regulatory information · Taiwan FDA cosmetic regulations · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS) · US FDA color additives · US FDA prohibited and restricted ingredients

Argentina · Brazil

• Field of application and/or use : Dye Substances allowed for all kinds of products.

ASEAN

• Maximum authorised concentration in the finished cosmetic product : 25%
• Other limitations and requirements : Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm, to be used in compliance with Annex III, No [338]. For the product types under letter (c) of column (c) in Annex III, No [338], the maximum concentration in ready for use preparation provided in column (d) of this entry applies.
• Maximum authorised concentration in the finished cosmetic product : 25%
• Other limitations and requirements : Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. 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 can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects, - Photocatalytic activity ≤ 10% compared with corresponding non-coated or non-doped reference, - Nanoparticles are photostable in the final formulation.
• Field of application : Colouring agents allowed in all cosmetic products
• Other limitations and requirements : Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm, to be used in compliance with Annex III, No [338]

Canada

• Maximum Concentration Permitted : ≤ 25%

United States

• Specific Limitations and Comments : Use of the term ""sunscreen"" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, ""Contains a sunscreen to protect product color."" If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products
• Eye Area : Yes
• Generally (Includes Lipsticks) : Yes
• External Use : Yes

China

• Maximum concentration : 25%

South Korea

• ∙ 25%
• CI Number : CI 77891

European Union

• Maximum concentration in ready for use preparation : 25% - In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25%
• Wording of conditions of use and warnings : Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation 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, — coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone; or coated with one of the follow­ing combinations: —Silica at a maximum concen­tration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %, —Alumina at a maximum con­centration of 7 % and Manga­nese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products), —Alumina at a maximum con­centration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %, — photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped re­ference, — nanoparticles are photostable in the final formulation.
• Maximum concentration in ready for use preparation : 25% In case of combined use of Titanium Dioxide and Titanium Dioxide (nano) , the sum shall not exceed the limit of 25%
• Other : Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321. For the product types under letter (c) of column (f) in Annex III, No 321, the maximum concentration in ready for use preparation provided in column (g) of this entry applies. (For use as a colourant, see Annex IV, No 143)

Not classified under Korea’s toxic-substance GHS list · existing chemical substance

Source: Korea toxic substances GHS register (NIER)

EU Cosmetics Regulation, Annex IV (allowed colourants), entry 143

Source: EU allowed colourants (Annex IV)

Restriction IV/143

Source: EU CosIng ingredient list

Restriction IV/143 VI/27 VI/27a (nano) · Other restriction: ban substances that deplete the ozone layer · SCCS opinion: Opinion for clarification of the meaning of the term "sprayable applications/products" for the nano forms of Carbon Black CI 77266, Titanium Oxide and Zinc Oxide; Opinion on Titanium Dioxide; OPINION ON Titanium Dioxide (nano form) as UV-Filter in sprays; OPINION ON Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetic

Source: EU CosIng ingredient list