Titanium dioxide

Titanium dioxide in plain language

What it is

On cosmetic ingredient lists it appears as “CI 77891”.

Also known as CI 77891 · Titanium dioxide (nano) · Titanium oxide · CI pigment white 6 · Titania · Titanium Dioxide/CI 77891

Show all 33 names

C.I. 77891 · Ci-pigment white 6 · Rutile · Rutile (TIO2) · Sagenite · Aerolyst 7708 · Aerolyst 7710 · Aerolyst 7711 · Aerosil P 25 · Aerosil P 25S6 · Aerosil P 27 · Aeroxide P 25 · CI-(1975)NO.77891 · E 171 · Ins NO.171 · INS-171 · Kaolin Clay · Pigment · Recycled Powder · TiO2 · Titanium Dioxide Pigment · Titanium dioxide (CI 77891) · Titanium(IV) oxide · Titatnium Dioxide · Undisclosed · White Tint · titanii dioxidum

What it does

Used in cosmetics as a UV filter, a colourant and an opacifier. CI 77891 is classed chemically as an inorganic colour (see also INCI: Titanium dioxide).

• UV filter
• UV absorber
• Colorant
• Opacifying
• Colour
• Colourant

Is it a concern?

Critical concern: no hazard classifications on record. It is restricted in EU cosmetics.

Why it's flagged

Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm is restricted in cosmetic products under Annex III of the EU Cosmetics Regulation (EC) 1223/2009.

RestrictedEU EC — restricted

The score describes this ingredient's chemical identity — its hazard profile from published classifications and regulatory status — not the safety of any product it appears in.

• In marketed US drugs
• EU Annex III — restricted
• EU Annex IV — permitted colorant
• EU Annex VI — permitted UV filter
• EU permitted colorant
• EU permitted UV filter
• EU restricted in cosmetics
• Inactive ingredient in US drugs

• EU·EC

  Annex III of EU Cosmetics Regulation (EC) 1223/2009: substances which cosmetic products must not contain except subject to the restrictions laid down. Product types: (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

  restricted
  View source →

• US·FDA·inactive ingredient database40 entries — 9 administration routes

  • Route: ORAL; Dosage form: CAPSULE, COATED; Maximum daily exposure: 17 mgSource →
  • Route: ORAL; Dosage form: CAPSULE, COATED PELLETS; Potency: 4.4 mgSource →
  • Route: ORAL; Dosage form: CAPSULE, COATED, EXTENDED RELEASE; Potency: NASource →
  • Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE; Maximum daily exposure: 55 mgSource →
  • Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE PELLETS; Maximum daily exposure: 24 mgSource →
  • Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 67 mgSource →
  • Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Maximum daily exposure: 12 mgSource →
  • Route: ORAL; Dosage form: DROPS; Potency: NASource →
  • Route: ORAL; Dosage form: FILM, SOLUBLE; Maximum daily exposure: 2 mgSource →
  • Route: ORAL; Dosage form: GRANULE, FOR SUSPENSION; Maximum daily exposure: 143 mgSource →
  • Route: ORAL; Dosage form: POWDER; Potency: 2 mgSource →
  • Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Maximum daily exposure: 297 mgSource →
  • Route: ORAL; Dosage form: SUSPENSION; Maximum daily exposure: 113 mgSource →
  • Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 232 mgSource →
  • Route: ORAL; Dosage form: TABLET, COATED; Maximum daily exposure: 49 mgSource →
  • Route: ORAL; Dosage form: TABLET, DELAYED RELEASE; Maximum daily exposure: 66 mgSource →
  • Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 90 mgSource →
  • Route: ORAL; Dosage form: TABLET, FILM COATED; Maximum daily exposure: 36 mgSource →
  • Route: ORAL; Dosage form: TABLET, FILM COATED, EXTENDED RELEASE; Maximum daily exposure: 11 mgSource →
  • Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING; Maximum daily exposure: 6 mgSource →
  • Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; Maximum daily exposure: 42 mgSource →
  • Route: RESPIRATORY (INHALATION); Dosage form: CAPSULE; Potency: NASource →
  • Route: RESPIRATORY (INHALATION); Dosage form: POWDER; Potency: 2 mgSource →
  • Route: TOPICAL; Dosage form: CREAM; Maximum daily exposure: 80 mgSource →
  • Route: TOPICAL; Dosage form: GEL; Potency: 0.06 %w/wSource →
  • Route: TOPICAL; Dosage form: LOTION; Potency: NASource →
  • Route: TOPICAL; Dosage form: OINTMENT; Potency: 5 %w/wSource →
  • Route: TOPICAL; Dosage form: SHAMPOO, SUSPENSION; Potency: 3 %w/vSource →
  • Route: TOPICAL; Dosage form: SOAP; Potency: 1 %w/wSource →
  • Route: TOPICAL; Dosage form: SYSTEM; Maximum daily exposure: 420 mgSource →
  • Route: TRANSDERMAL; Dosage form: FILM, EXTENDED RELEASE; Potency: NASource →
  • Route: VAGINAL; Dosage form: SUPPOSITORY; Potency: NASource →
  • Route: INTRAUTERINE; Dosage form: SUPPOSITORY, EXTENDED RELEASE; Potency: 1 mgSource →
  • Route: DENTAL; Dosage form: PASTE, DENTIFRICE; Potency: 0.4 %w/wSource →
  • Route: DENTAL; Dosage form: PASTE; Potency: 0.5 %w/wSource →
  • Route: BUCCAL; Dosage form: GUM, CHEWING; Maximum daily exposure: 182 mgSource →
  • Route: BUCCAL; Dosage form: FILM, SOLUBLE; Maximum daily exposure: 11 mgSource →
  • Route: BUCCAL; Dosage form: FILM; Maximum daily exposure: 3 mgSource →
  • Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 72 mgSource →
  • Route: OPHTHALMIC; Dosage form: INSERT, EXTENDED RELEASE; Potency: 0.4 mgSource →
• EU·CosIng·Active6 entries

  • CI 77891 is classed chemically as an inorganic colour (see also INCI: Titanium dioxide). It conforms to the formula Restriction: IV/143Source →
  • Titanium Dioxide is the inorganic oxide. To identify the colourant meeting the requirements for labelling purposes in the EU, the INCI Name 77891 must be used. It conforms generally to the formula: Restriction: IV/143 VI/27 VI/27a (nano)Source →
  • Cosmetics Regulation annex VI / ref 27.Source →
  • Cosmetics Regulation annex IV / ref 143.Source →
  • Cosmetics Regulation annex VI / ref 27a.Source →
  • Cosmetics Regulation annex III / ref 321.Source →
• EU·EFSA·EFSA opinion6 entries

  • Safety assessment of titanium dioxide (E171) as a food additive (EFSA FAF)Source →
  • Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and materials in Contact with Food on a request from the Commission related to the safety in use of rutile titanium dioxide as an alternative to the presently permitted anatase form (EFSA AFC)Source →
  • Re-evaluation of titanium dioxide (E 171) as a food additive (EFSA ANS)Source →
  • Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171) (EFSA ANS)Source →
  • Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution (EFSA FAF)Source →
  • Safety and efficacy of a feed additive consisting of titanium dioxide for all animal species (Kronos International, Inc.) (EFSA FEEDAP)Source →
• EU·EC·allowed_listed3 entries

  • Annex IV of EU Cosmetics Regulation (EC) 1223/2009: colorants allowed in cosmetic products. Conditions of use and 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)Source →
  • Annex VI of EU Cosmetics Regulation (EC) 1223/2009: UV filters allowed in cosmetic products. Maximum concentration: 25% - In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25%. 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…Source →
  • Annex VI of EU Cosmetics Regulation (EC) 1223/2009: UV filters allowed in cosmetic products. 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)Source →
• US·FDA·marketed drug occurrence2 entries

  • FDA NDC lists this ingredient in 1 active drug products and 1 total products.Source →
  • FDA NDC lists this ingredient in 2721 active drug products and 2777 total products.Source →
• GLOBAL·JECFA·EvaluatedJECFA evaluation record.

  • JECFA evaluation record.Source →
• GLOBAL·JECFA·NOT LIMITED (not specified)JECFA evaluation lists ADI NOT LIMITED (not specified). Functional class: colour.

  • JECFA evaluation lists ADI NOT LIMITED (not specified). Functional class: colour.Source →
• US·EPA·commercial use observedEPA CPDat observed this chemical in 41617 composition records across product categories including Construction and building materials, Raw materials, Furniture and furnishings. EPA CPDat classifies this chemical for functional uses including Pigment, Dye, Brightener.

  • EPA CPDat observed this chemical in 41617 composition records across product categories including Construction and building materials, Raw materials, Furniture and furnishings. EPA CPDat classifies this chemical for functional uses including Pigment, Dye, Brightener.Source →
• US·FDA·listed in openFDA substanceopenFDA substance registry classifies this ingredient as chemical.

  • openFDA substance registry classifies this ingredient as chemical.Source →

Expert safety opinions

Independent scientific assessments cited by the records we hold, with the year and link where the record gives one.

• SCCS

  EU Scientific Committee on Consumer Safety

  No SCCS opinion on file.

• CIR

  Cosmetic Ingredient Review (US expert panel)

  No CIR safety assessment on file.

• EFSA

  European Food Safety Authority

  • Safety assessment of titanium dioxide (E171) as a food additive (EFSA FAF)

    2021 · EU EFSA listing · Read the source →

  • Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and materials in Contact with Food on a request from the Commission related to the safety in use of rutile titanium dioxide as an alternative to the presently permitted anatase form (EFSA AFC)

    2005 · EU EFSA listing · Read the source →

  • Re-evaluation of titanium dioxide (E 171) as a food additive (EFSA ANS)

    2016 · EU EFSA listing · Read the source →

  • Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171) (EFSA ANS)

    2018 · EU EFSA listing · Read the source →

  • Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution (EFSA FAF)

    2019 · EU EFSA listing · Read the source →

  • Safety and efficacy of a feed additive consisting of titanium dioxide for all animal species (Kronos International, Inc.) (EFSA FEEDAP)

    2021 · EU EFSA listing · Read the source →

• JECFA

  Joint FAO/WHO Expert Committee on Food Additives

  • JECFA evaluation record.

    Year not recorded · GLOBAL JECFA listing · Read the source →

  • JECFA evaluation lists ADI NOT LIMITED (not specified). Functional class: colour.

    Year not recorded · GLOBAL JECFA listing · Read the source →

• LRLa Roche Posay LR
  Cicaplast Baume B5+La Roche Posay · Baumes Et Beurres Pour Le Corps
• CCoca-Cola C
  Zero calories Zero caffeine ZerosugarCoca-Cola · Beverages And Beverages Preparations
• UUnilever U
  Dove pamperingUnilever · Cosmetic Products
• VVaseline,Unilever V
  Vaseline lip therapyVaseline,Unilever · Face
• DDove D
  Refreshing beauty cream barDove
• GGreenveil G
  Chargement…Non Food Products
• Ddove,unilever D
  Beauty cream bardove,unilever · Soap
• DDeliplus D
  crema solar facialDeliplus
• CCeraVe C
  Hydrating cream-to-foam cleanserCeraVe · Face
• HVhenkel, vademecum HV
  Bio Protection Complètehenkel, vademecum · Hygiene
• LNLOGOCOS Naturkosmetik LN
  Limpiador, exfoliante y mascarilla arcilla blancaLOGOCOS Naturkosmetik
• JAJohnson and Johnson JA
  Le petit marseillaisJohnson and Johnson
• LRLa Roche Posay LR
  la Roche PosayLa Roche Posay
• GGreenveil G
  Vaseline daily brighteningNon Food Products
• UDunilever, dove UD
  Dove Savon Pain de Toilette Exfoliating Anti-Bactérien x1unilever, dove · Hygiene
• UVUnilever, Vaseline UV
  Vaseline Intensive Care Advanced Repair BodylotionUnilever, Vaseline · Bodylotion
• LPle petit marseillais LP
  Savons soin surgras huile d'amande doucele petit marseillais · Open Beauty Facts
• LPLe petit marseillais LP
  savon extra doux lait, main & corpsLe petit marseillais · Open Beauty Facts
• UDunilever, dove UD
  DOVE Crème Hydratante Corps Soie Pot 300mlunilever, dove · Body
• PPPalmolive, Palmolive Naturals PP
  Moisture Care with OlivePalmolive, Palmolive Naturals · Hygiene
• EEco+ E
  Dentifrice au fluorEco+ · Hygiene
• DDeliplus D
  Mascarilla sin aclarado Argan OilDeliplus · Open Beauty Facts
• LLa-roche-posay L
  Nutritic Lèvres - soin transformation lèvres desséchéesLa-roche-posay · Baumes A Levres
• LPLe Petit Olivier LP
  Savonnettes extra douces Fleur d'orangerLe Petit Olivier · Hygiene

• Co occurs
• Co occurs
• C.I. Pigment Brown 7Co occurs
• D&C red no. 7Co occurs
• CI 15850Co occurs
• Co occurs
• Fluorphlogopite (Mg3K[AlF2O(SiO3)​3]​)Co occurs
• Silica dimethyl silylateCo occurs
• Tin oxideCo occurs
• Tin oxideCo occurs
• Tin oxide (Sn3O6)Co occurs
• Ferric oxide redCo occurs