Titanium Dioxide
INCI: TITANIUM DIOXIDE
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 study endpoints found for Titanium Dioxide. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 1250 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 7500 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | mouse | Special Toxicology Study | COSMOS_DB |
| dose_tested | 5000 mg/kg bw/day | oral | mouse | Special Toxicology Study | COSMOS_DB |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
. The CIR Expert Panel concluded that dimethicone is safe in cosmetics in the present practices of use and reported concentration ranges when formulated to be non- irritating, with the exception that the available data are insufficient to make a determination of safety for use in products that
n light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered as safe when used as a food additive. In May 2022, the Commission services received a dossier submission by industry accompanied by a comprehensive and up to date review of the genetic toxicity database fo
n light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered as safe when used as a food additive. In May 2022, the Commission services received a dossier submission by industry accompanied by a comprehensive and up to date review of the genetic toxicity database fo
n light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered as safe when used as a food additive. In May 2022, the Commission services received a dossier submission by industry accompanied by a comprehensive and up to date review of the genetic toxicity database fo
n light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered as safe when used as a food additive. In May 2022, the Commission services received a dossier submission by industry accompanied by a comprehensive and up to date review of the genetic toxicity database fo
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Titanium Dioxide.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| - | - | Inhalation | Rat | Subchronic (90-day) (90 days (inhalation, 6h/day)) | N/A | SCCS/1617/20 (2020) |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Titanium Dioxide, relevant to systemic exposure and MoS calculations.
Source: SCCS/1516/13
Expert Verdict
One of only two FDA GRAS sunscreen actives. Strong UVB and UVA2 protection but absorption edge at ~350–360 nm means limited UVA1 coverage — routinely combined with ZnO or avobenzone for full broad-spectrum compliance. Nano grades (20–100 nm) reduce white cast by shifting visible scattering to UV-range. Critical formulation specs: rutile crystal phase only (anatase more photocatalytic), alumina+silica coating (most effective ROS suppression), EU spray ban compliance and nano labeling. SCCS 2025 reassessment covering all cosmetic product types is a live regulatory risk to monitor — opinion due approximately September 2026. Genotoxicity for oral exposure routes (lip products, toothpaste) already established — avoid in those formats pending new opinion. Reef-safe. Globally approved.
Regulatory Flags
Frequently Asked Questions
Is Titanium Dioxide safe in cosmetics?
One of only two FDA GRAS sunscreen actives. Strong UVB and UVA2 protection but absorption edge at ~350–360 nm means limited UVA1 coverage — routinely combined with ZnO or avobenzone for full broad-spectrum compliance. Nano grades (20–100 nm) reduce white cast by shifting visible scattering to UV-range. Critical formulation specs: rutile crystal phase only (anatase more photocatalytic), alumina+silica coating (most effective ROS suppression), EU spray ban compliance and nano labeling. SCCS 2025 reassessment covering all cosmetic product types is a live regulatory risk to monitor — opinion due approximately September 2026. Genotoxicity for oral exposure routes (lip products, toothpaste) already established — avoid in those formats pending new opinion. Reef-safe. Globally approved. The EU classifies Titanium Dioxide as "restricted". Safety rating: EXCELLENT. 4 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.
Is Titanium Dioxide allowed in the EU?
Titanium Dioxide EU regulatory status: restricted. Maximum allowed concentration: 25% as UV filter; nano form (20–100 nm range) permitted with specific coating requirements (silica, alumina, dimethicone, stearic acid); banned in spray products. This is based on EU Regulation 1223/2009 and its amendments.
What does Titanium Dioxide do in cosmetics?
Titanium Dioxide functions as: Inorganic UV filter (UVB-primary, limited UVA1); absorption edge ~350–360 nm provides strong UVB and UVA2 coverage with limited UVA1 protection above 360 nm; reflects, scatters, and absorbs UV; rutile polymorph preferred for sunscreens (lower photocatalytic activity than anatase); also used as opacifier and colorant (CI 77891). It is classified as a Active Ingredient in our database. CAS number: 13463-67-7.
What is the Margin of Safety for Titanium Dioxide?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Titanium Dioxide?
The NOAEL (No Observed Adverse Effect Level) for Titanium Dioxide is 1250 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 4 study endpoints are available. Source: COSMOS_DB.
Is Titanium Dioxide classified as hazardous under GHS?
Titanium Dioxide carries a GHS signal word of "DANGER". Hazard statements: Causes damage to respiratory system through prolonged or repeated exposure if inhaled Suspected of causing cancer. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Compliance Tools
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