Permitted under conditionsAnx. IIIRef. III/321

TITANIUM DIOXIDE

COLORANT · OPACIFYING · UV ABSORBER · UV FILTER

CAS
13463-67-7
EC
236-675-5
IUPAC
Titanium Dioxide
Max conc.
(a) 25 %; (b) 1,4 % for general consu­mers, and 1.1 % for pro­fessional use.

Last CosIng update

23 March 2022

Description

Annex III/321 — TITANIUM DIOXIDE

TITANIUM DIOXIDE is an inorganic titanium oxide. In cosmetic products it performs the functions of colorant (COLORANT), opacifying agent (OPACIFYING), ultraviolet absorber (UV ABSORBER) and ultraviolet filter (UV FILTER).

The ingredient is listed in Annex III of Regulation (EC) No 1223/2009, reference 321. The maximum authorized concentration is set as "(a) 25 %; (b) 1,4 % for general consumers, and 1.1 % for professional use." The authorized product type is restricted to "(a) face products in loose powder form", "(b) hair aerosol spray products" and "(c) other products". The specific conditions indicate that for uses (a) and (b) "Only in the pigmentary form" is admitted, and for (c) "Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation". It has no CMR classification or additional mandatory labelling warnings. In addition, cross entries are recorded in Annex IV, reference 143, and in Annex VI, references 27 and 27a (nano), the latter specific to the nanoscale form of the ingredient.

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

Annex VI/27 — TITANIUM DIOXIDE

Titanium Dioxide (INN: titanium dioxide; Ph.Eur: titanii dioxidum) is an inorganic oxide. Its declared technical functions are COLORANT, OPACIFYING, UV ABSORBER and UV FILTER. In cosmetics generally, colorants are used to impart tint to the finished product; opacifying agents reduce the transparency of a phase or of a formula; UV absorbers attenuate the incidence of ultraviolet radiation on components of the formulation; and UV filters are ingredients intended to protect the skin against solar radiation within the regulatory framework applicable to sun protection cosmetic products.

The substance is listed in Annex VI, reference 27, of Regulation (EC) No 1223/2009 on cosmetic products. The maximum authorized concentration in the ready-to-use preparation is "25%*", with the literal note: "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)". Among the additional conditions it is established: "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". It also states: "(For use as a colourant, see Annex IV, No 143)".

In cosmetic formulations, colorants are used to impart color to the product; opacifying agents help modify the visual appearance of the phase or base; UV absorbers are incorporated to reduce the incidence of ultraviolet radiation on components of the formula; and UV filters are used in specific categories intended for skin sun protection, within the limits and conditions set by the applicable regulatory framework. The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.

Annex IV/143 — TITANIUM DIOXIDE/CI 77891

TITANIUM DIOXIDE/CI 77891 is an inorganic oxide; that is the term used by the chemical description of TITANIUM DIOXIDE in the CosIng inventory, whereas that of CI 77891 classes it as an inorganic colorant. The chemical name of the entry, Titanium Dioxide/CI 77891, combines the chemical designation and the Colour Index number. In the inventory, CI 77891 has the declared colorant function, and TITANIUM DIOXIDE the colorant, opacifying, UV absorber and UV filter functions. In general, a colorant gives color to the product or the application area, and an opacifier reduces the transparency of the formula.

The substance is included in Annex IV of Regulation (EC) No 1223/2009, the list of permitted colorants, with reference 143, and its declared color is white. The warnings field of the entry combines three indications, which read verbatim: "— 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)". The first refers, for the purity criteria, to a Commission directive and to code E 171; the second refers to Annex III for titanium dioxide in powder form with 1% or more of particles with an aerodynamic diameter ≤ 10 μm, and the third to Annex VI for its use as a UV filter. In the inventory, the cosmetic restriction of TITANIUM DIOXIDE and CI 77891 includes IV/143.

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

Annex VI/27a — TITANIUM DIOXIDE (NANO)

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

(a) 25 %; (b) 1,4 % for general consu­mers, and 1.1 % for pro­fessional use.

§

Regulatory framework

Regulation (EC) No 1223/2009 — Annex III, ref. 321

Last update reflected in the database: 23 March 2022

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Conditions of 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 inhalation

Product type: (a) face products in loose powder form (b) hair aerosol spray pro­ducts (c) other products

Recent analyses mentioning this ingredient

  • SeguimientoOpinión científica SCCS · 25 de octubre de 2024
    SCCS Opinion on new coating for Titanium Dioxide (nano form)

    El SCCS concluyó que no puede determinar la seguridad del Titanium Dioxide (nano) con recubrimiento Eclipse 70 (Aluminium Hydroxide 6% + Sodium Myristoyl Sarcosinate 14% + Dimethicone 10%) por lagunas de datos en propiedades fisicoquímicas, estabilidad del recubrimiento y absorción dérmica. Si tu empresa usa o planea usar este TiO2 nano específico (Eclipse 70), ese grado no está aprobado todavía; los grados de TiO2 nano aprobados en la opinión anterior (SCCS/1516/13) siguen válidos. El solicitante indicó que presentará un dossier corregido; monitoreá el proceso.

  • SeguimientoConsejo científico SCCS · 23 de mayo de 2024
    Scientific Advice on Titanium dioxide (TiO2) (CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/215-280- 1, 1317-80-2/215-282-2)

    El SCCS (SCCS/1661/23) concluye que la genotoxicidad del dióxido de titanio (TiO2) no puede excluirse para casi todos los grados usados en productos cosméticos orales (dentífricos, enjuagues) o de inhalación, salvo dos grados nano específicos (RM09 y RM11) bajo ciertas condiciones. Las opiniones anteriores sobre uso dérmico (SCCS/1516/13, SCCS/1580/16) permanecen sin cambios. Las empresas deben: (1) verificar que sus TiO2 no sean de grados aún no evaluados como seguros si se usan en productos orales o en aerosol; (2) no usar TiO2 en formulaciones que puedan llegar a los pulmones por inhalación (ya restringido en Anexo VI, entrada 27a); (3) estar atentas a potenciales restricciones adicionales para productos orales pendientes de datos de genotoxicidad complementarios.

Data source: Official CosIng from the European Commission, updated on 23 March 2022. Learn more →