Compoatlas

TITANIUM DIOXIDE

Official label name (INCI name, EU glossary of cosmetic ingredient names), No 28903

TITANIUM DIOXIDE: Allowed with restrictions, with limits depending on the product type, for the form named in the entry: “Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm” (Annex III, entry 321); UV filter allowed under conditions, with limits depending on the product type (Annex VI, entry 27a); colorant allowed under conditions (Annex IV, entry 143), under Regulation (EC) No 1223/2009.

In plain words

What it is used for

Functions declared by manufacturers:

Colorant: colours cosmetics and/or imparts colour to the skin and/or its appendages.

Opacifying: reduces transparency or translucency of cosmetics.

UV absorber: protects the cosmetic product from the effects of UV light.

UV filter: filters certain UV rays in order to protect the skin or the hair from harmful effects of these rays.

What the rules say

Allowed, with restrictions: Annex III sets a maximum concentration and the product types allowed. Ingredient lists do not give quantities, so the concentration cannot be checked on the label.

An ingredient can be used as a UV filter only if it appears on the list of Annex VI. <function plain_language.<locals>.name at 0x7f7805a959e0> is on it with a maximum concentration and with a warning to print.

An ingredient can be used as a colorant only if it appears on the list of Annex IV. <function plain_language.<locals>.name at 0x7f7805a959e0> is on it with a warning to print.

Hazard and risk

Its classification as carcinogenic, category 2 (suspected effect, without enough evidence for a higher category) under the CLP Regulation was annulled by the EU courts, judgment of the Court of Justice of 1 August 2025 (Joined Cases C-71/23 P and C-82/23 P), upholding the judgment of the General Court of 23 November 2022 (T-279/20, T-283/20 and T-288/20). It no longer applies.

The text of the annexes

Allowed with restrictions

Entry
Annex III, No 321
Substance
Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm
Glossary names
TITANIUM DIOXIDE
CAS
13463-67-7/ 1317-70-0/ 1317-80-2
EC
236-675-5/ 215-280-1/ 215-282-2
Product type
(a) face products in loose powder form (b) hair aerosol spray pro­ducts (c) other products
Maximum concentration
(a) 25 %; (b) 1,4 % for general consu­mers, and 1.1 % for pro­fessional use.
Other conditions
a) (b) Only in the pigmentary form (c) Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation
Dates in the act (3)
  • Entry into force on 17 June 2021
  • Application from 1 October 2021
    Article 1 shall apply from 1 October 2021 with respect to points (1), (2) (b), (3) and (4) of the Annex.
  • Entry into force on 1 October 2021

Excerpts from the English text published in the Official Journal. A date may concern only some substances of the act: the excerpt says so.

UV filter allowed under conditions

This entry covers the same substance as TITANIUM DIOXIDE (same CAS number in the CosIng inventory): its conditions apply.

Entry
Annex VI, No 27a
Substance
Titanium dioxide (nano)
Glossary names
TITANIUM DIOXIDE (NANO)
CAS
13463-67-7[1]/ 1317-70-0[2]/ 1317-80-2[3]
EC
236-675-5[1] /215-280-1[2]/ 215-282-2[3]
Maximum concentration
25% - In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25%.
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.
Dates in the act (1)
  • Entry into force on 27 November 2019

Excerpts from the English text published in the Official Journal. A date may concern only some substances of the act: the excerpt says so.

UV filter allowed under conditions

Entry
Annex VI, No 27
Substance
Titanium Dioxide
Glossary names
TITANIUM DIOXIDE
CAS
13463-67-7[1]/ 1317-70-0[2]/ 1317-80-2[3]
EC
236-675-5[1] /215-280-1[2]/215-282-2 [ 3]
Maximum concentration
25%* *: In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g (Maximum concen­tration in ready for use preparation)
Other conditions
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)
Dates in the act (10)
  • Entry into force on 11 January 2010
  • Application from 1 December 2010
    It shall apply from 11 July 2013, with the exception of: — Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and — Article 16(3) second subparagraph, which shall apply from 11 January 2013.
  • Entry into force on 1 December 2010
  • Condition applicable from 11 January 2012
    As from 11 January 2012, by way of derogation from Directive 76/768/EEC, notification carried out in accordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and Article 7a(4) of that Directive
  • Application from 11 January 2013
    July 2013, with the exception of: — Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and — Article 16(3) second subparagraph, which shall apply from 11 January 2013.
  • Entry into force on 11 January 2013
  • Application from 11 July 2013
    It shall apply from 11 July 2013, with the exception of: — Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and — Article 16(3) second subparagraph, which shall appl
  • Entry into force on 11 July 2013
  • Placing on the market before 11 July 2013
    Article 39 Transitional provisions By way of derogation from Directive 76/768/EEC, cosmetic products which comply with this Regulation may be placed on the market before 11 July 2013.
  • Placing on the market from 11 July 2013
    As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following info

Excerpts from the English text published in the Official Journal. A date may concern only some substances of the act: the excerpt says so.

Colorant allowed under conditions

Entry
Annex IV, No 143
Substance
Titanium Dioxide/CI 77891
Glossary names
TITANIUM DIOXIDE/CI 77891
CAS
13463-67-7
EC
236-675-5
Warnings
— Purity criteria as set out in Commission Directive 95/45/E (E 171) — 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 use as a UV filter, see Annex VI, No 27)
Dates in the act (10)
  • Entry into force on 11 January 2010
  • Application from 1 December 2010
    It shall apply from 11 July 2013, with the exception of: — Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and — Article 16(3) second subparagraph, which shall apply from 11 January 2013.
  • Entry into force on 1 December 2010
  • Condition applicable from 11 January 2012
    As from 11 January 2012, by way of derogation from Directive 76/768/EEC, notification carried out in accordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and Article 7a(4) of that Directive
  • Application from 11 January 2013
    July 2013, with the exception of: — Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and — Article 16(3) second subparagraph, which shall apply from 11 January 2013.
  • Entry into force on 11 January 2013
  • Application from 11 July 2013
    It shall apply from 11 July 2013, with the exception of: — Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and — Article 16(3) second subparagraph, which shall appl
  • Entry into force on 11 July 2013
  • Placing on the market before 11 July 2013
    Article 39 Transitional provisions By way of derogation from Directive 76/768/EEC, cosmetic products which comply with this Regulation may be placed on the market before 11 July 2013.
  • Placing on the market from 11 July 2013
    As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following info

Excerpts from the English text published in the Official Journal. A date may concern only some substances of the act: the excerpt says so.

Identity

CosIng identifier
38617
CAS (according to CosIng)
13463-67-7
EC (according to CosIng)
236-675-5
Declared functions
Colorant, Opacifying, UV absorber, UV filter

The CAS number cited by CosIng also covers 1 other INCI name: it designates a family of substances, not this ingredient alone.

Classified hazard (CLP Regulation)

A classification describes an intrinsic hazard, not a risk: the risk depends on the dose, the form and the exposure.

titanium dioxide; [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm]

CMR Carc. 2, classification annulled

Hazard classes
Carc. 2
Hazard statements
H351 (inhalation)
CLP notes
V, W, 10

Classification annulled by the EU courts, judgment of the Court of Justice of 1 August 2025 (Joined Cases C-71/23 P and C-82/23 P), upholding the judgment of the General Court of 23 November 2022 (T-279/20, T-283/20 and T-288/20). It no longer applies, even though the consolidated text of the CLP Regulation still includes it.

EU product alerts (Safety Gate)

2 alerts on cosmetic products cite this name in their hazard description. An alert targets a specific product, not the ingredient itself; each alert states the reason (prohibited substance, limit exceeded, missing labelling, and so on).

  • 17 July 2009: Skin cream - Exclusiv-Vital –Basische Frische-Kosmetik, Siriderma, Germany (“Serious risk”) alert
  • 17 July 2009: Skin cream - Exclusiv-Vital – Basische Frische-Kosmetik-, Siriderma, Germany (“Serious risk”) alert

Elsewhere in the world

Information on other jurisdictions. What is covered, and what is not yet.

United Kingdom (Great Britain)

  • UV filter allowed under conditions (Annex VI)
  • Colorant allowed under conditions (Annex IV)

Entry 321 of Annex III of EU law (Regulation (EU) 2021/850) has no equivalent in British law.

Switzerland

Regulation (EC) No 1223/2009 applies in Switzerland (Article 54 of the Ordinance on Foodstuffs and Utility Articles).

United States, federal rules

None of the integrated sections of the federal code (21 CFR 700.11 to 700.27 and 250.250) targets this name. The FDA does not publish a list of allowed ingredients.

South Korea

  • Allowed colorant: 티타늄디옥사이드 (Titanium Dioxide) CI 77891 (Titanium Dioxide)

    색소 고시 별표 1 (allowed colorants), entry 89, page 5.

  • Restricted: 티타늄디옥사이드 (TITANIUM DIOXIDE)

    별표 2, 자외선 차단성분 (UV filters), entry 30, page 17. Limit: 25%.

Australia

  • Active ingredient allowed in sunscreens: TITANIUM DIOXIDE

    Permissible Ingredients Determination (No. 3) 2026, sunscreen actives, entry 4952, page 206. Thresholds cited: must be no more than 25%. Conditions (source text): Purpose: A, E | For use as an active ingredient only in sunscreens for dermal application. | The concentration in sunscreens must be no more than 25%. | For use as an excipient only as a colour and only in medicines limited to oral and topical routes of administration. | Not to be included in medicines intended for use in the eye. | When used in primary sunscreen products, the following warning statements are required on the label: | - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and | - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

Brazil

  • Allowed under conditions: Dióxido de titânio TITANIUM DIOXIDE (TITANIUM DIOXIDE)

    RDC 600/2022, Anexo (allowed UV filters), entry 18, page 3. Limit: 25%.

Recorded cosmetics that contain it

692 recorded products list it, according to Open Beauty Facts contributors. Records are dated: the formula may have changed. See the list (page in French).

Glossary: Commission Implementing Decision (EU) 2025/1175. Page updated on 21 October 2026.