RegulatedAnx. VIRef. VI/27a

Titanium dioxide (nano)

CAS
1317-70-0, 1317-80-2, 13463-67-7
IUPAC
Titanium dioxide [1];Anatase (TiO2) [2];Rutile (TiO2) [3]
Reference
VI/27a
Max conc.
25% - In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25%.

Last CosIng update

28 July 2020

Description

Titanium Dioxide (nano) is an inorganic metal oxide corresponding to the nanoparticulate form of titanium dioxide.

This ingredient is regulated in Annex VI, reference 27a, with a maximum authorized concentration of "25%". The regulations state that "In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25%." Only nanomaterials with purity ≥ 99%, rutile form or rutile with up to 5% anatase, median particle size ≥ 30 nm, aspect ratio of 1 to 4.5, volume-specific surface area ≤ 460 m²/cm³, photocatalytic activity ≤ 10% relative to the uncoated reference material and photostability in the final formulation are admitted, with specific coatings listed (including Silica, Alumina, Stearic Acid, Dimethicone and specified combinations). The literal labelling warning states: "Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation." For facial products containing the combination of Alumina and Manganese Dioxide: "Not to be used on the lips."

The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.

Detailed EU regulation

%

Maximum permitted concentration

25% - In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25%.

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Regulatory framework

Regulation (EC) No 1223/2009 — Annex VI, ref. 27a

Last update reflected in the database: 28 July 2020

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Labelling 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. Wording of conditions of use and warnings: For face products containing Tita­nium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips.

Recent analyses mentioning this substance

No analyses published yet for this substance. This section will be filled with regulatory blog articles as they are published.

Data source: Official CosIng from the European Commission, updated on 28 July 2020. Learn more →