Ingredient source facts

Titanium dioxide (nano): EU cosmetic annex conditions and formula evidence

Titanium dioxide (nano) has identifier matches to Annex III, Annex IV, Annex VI in the acquired 18 May 2026 EU Cosmetics Regulation text. The table distinguishes the substance identity, product-use conditions and recorded limits. Confirm the exact substance/group scope, formula concentration and intended use before applying an entry. This does not certify formula safety or settle Great Britain requirements. The informative CosIng metadata and legal-table references differ; this page does not treat them as interchangeable.

Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.

Exact legal-entry matches and product-use conditions

Exact checksum-valid CAS and/or exact EC identifier in preserved legal identity cells. Group and substance scope are still conditional.

Each line below retains its own concentration basis, conditions and warnings. Blank source cells mean no condition was recorded in that cell; they do not establish unrestricted use.

Annex III · Entry 321

Recorded identity: Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm

Matching CAS: 1317-70-0, 1317-80-2, 13463-67-7 · Matching EC: 215-280-1, 215-282-2, 236-675-5

Product use / body siteMaximum concentration and basisOther conditionsWarningsSource
(a) face products in loose powder form (b) hair aerosol spray products (c) other products(a) 25 %; (b) 1,4 % for general consumers, and 1.1 % for professional use.(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 inhalationBlank in source[2]

Annex IV · Entry 143

Recorded identity: Titanium dioxide ( 1 )

Matching CAS: No exact CAS match · Matching EC: 236-675-5

Product use / body siteMaximum concentration and basisOther conditionsWarningsSource
Blank in sourceBlank in source— 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 321Blank in source[3]

Linked notes for this entry

  • ( 1 ) For use as a UV filter, see Annex VI, No 27 [4]

Annex VI · Entry 27

Recorded identity: Titanium dioxide ( 2 )

Matching CAS: 1317-70-0, 1317-80-2, 13463-67-7 · Matching EC: 215-280-1, 215-282-2, 236-675-5

Product use / body siteMaximum concentration and basisOther conditionsWarningsSource
Blank in source25 % ( 4 )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.Blank in source[5]

Linked notes for this entry

  • ( 2 ) For use as a colorant, see Annex IV, No 143. [6]
  • ►M16 ( 4 ) In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g. ◄ [7]

Annex VI · Entry 27a

Recorded identity: Titanium dioxide ( 2 )

Matching CAS: 1317-70-0, 1317-80-2, 13463-67-7 · Matching EC: 215-280-1, 215-282-2, 236-675-5

Product use / body siteMaximum concentration and basisOther conditionsWarningsSource
Blank in source25 % ( 4 )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 m 2 /cm 3 , — 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.For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips.[8]

Linked notes for this entry

  • ( 2 ) For use as a colorant, see Annex IV, No 143. [6]
  • ►M16 ( 4 ) In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g. ◄ [7]

The consolidated text is a dated reference. Current amendments, corrigenda and applicability dates must be checked. EU evidence does not resolve Great Britain rules.

Known facts and deciding inputs

Known context: EU. Ingredient identity is recorded; concentration, intended use, exposure and current legal conditions still need checking.

Source factRecorded valueWhat to check
INCI / recorded nameTitanium dioxide (nano) [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
Common ingredients glossary nameTITANIUM DIOXIDE (NANO) [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
CAS identifiers13463-67-7[1]/ 1317-70-0[2]/ 1317-80-2[3] [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
EC identifiers236-675-5[1] /215-280-1[2]/ 215-282-2[3] [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
Informative CosIng functionsUV FILTER [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
Chemical nameTitanium dioxide [1];Anatase (TiO2) [2];Rutile (TiO2) [3] [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
CosIng annex referenceVI [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
CosIng reference entry27a [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
maximumConcentration25% - In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25%. [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
wordingOfConditionsNot 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. [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
SCCS opinion referenceOpinion on Titanium Dioxide, 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 (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 [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
Related regulation reference(EU) 2019/1857 [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.
Recorded publication date2019-11-07T00:00:00.000+0100 [1]Check identity, concentration, exposure and use against the current legal annex and any amendments.

Resolve the entry against your actual formula

Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.

  1. Does the supplied material fall within these exact entries?

    Put your supplier CAS/EC, substance composition, salt/group membership, purity, physical form and intended function beside each matched entry. A matching identifier does not resolve every group or impurity condition.

    Useful evidence: Supplier specification, composition and certificates of analysis; the exact annex rows above.

  2. Which row governs the finished-product use?

    Compare the finished-product concentration, body site, rinse-off/leave-on use, consumer/professional setting and any exposure restrictions with each row. Preserve the units and calculation basis; do not transfer a limit from a different product-use row.

    Useful evidence: Quantitative formula and use instructions; a row-by-row condition and warning worksheet.

  3. Is a prohibition or trace question involved?

    For Annex II matches, review Article 14 before formulation decisions. Article 17 concerns a separate, conditional non-intended trace situation; it does not grant blanket permission to intentionally add a prohibited substance. Record origin and technical-avoidability evidence for specialist review.

    Useful evidence: Ingredient/impurity origin, manufacturing controls, trace quantities and the cited Article 17 text.

  4. What must reach the safety assessor and Responsible Person?

    Send the reconciled identity, condition table, exposure facts, supplier evidence and unresolved amendment/date questions. Agree formula, assessment and PIF responsibilities before notification or manufacturing handoff.

    Useful evidence: A dated formula-evidence matrix, supplier data, exposure description and document ownership list.

Work packages and dependencies

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Questions for providers

Sources and data dates

Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.

EUR-Lex — Regulation (EU) 2009/1223 ↗

Consolidated text dated 2026-05-18 · retrieved 2026-10-06

Audit details: precise locators and snapshot identifiers

Source key D05 · snapshot fc7ca1c1b06e5052fbfd81afd57c8ba69d4c215a4fc4a2a8385b9bff94a7b591

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