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INCI Name
Titanium dioxide [nano]
English name
Nano-Titanium Dioxide
CAS No.
13463-67-7
CE No.
236-675-5

Origins

  • Mineral

CosIng functions

  1. Opacifying Agent
  2. Sunscreen
  3. Colorant (White)

Regulation

Cosmetics Regulation 1223/2009, Annex IV/143 (Colorants)

Colour index Number/Name of Common Ingredients Glossary
• 77891

Colour
• White

Conditions
• Purity criteria as set out in Commission Directive 95/45/EC* (E171)
*Repealed by Directive 2008/128, itself repealed by Regulation231/2012
> Loss on drying: Not more than 0.5% (105°C, 3 hours)
> Loss on ignition: Not more than 1.0% on a volatile matter free basis (800°C)
> Aluminium oxide and/or silicon dioxide: Total not more than 2.0%
> Matter soluble in 0.5 N HCl: Not more than 0.5% on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1.5% on the basis of the product as sold
> Water soluble matter: Not more than 0.5%
> Cadmium: Not more than 1 mg/kg after an extraction with 0.5 N HC
> Antimony: Not more than 2 mg/kg after an extraction with 0.5 N HCl
> Arsenic: Not more than 1 mg/kg after an extraction with 0.5 N HCl
> Lead: Not more than 10 mg/kg after an extraction with 0.5 N HCl
> Mercury: Not more than 1 mg/kg after an extraction with 0.5 N HCl

Labelling
• For use as a colorant, must be declared under the INCI name: CI 77891

Cosmetics Regulation 1223/2009, Annex VI/27 (UV filters)

Chemical name/INN/XAN
• Titanium dioxide

Name of Common Ingredients Glossary
• Titanium Dioxide

Maximum concentration in ready for use preparation (finished cosmetic products)
• 25%*
*In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed 25%.

Labelling
• For use as a UV filter, must be declared under the INCI name: Titanium dioxide

Cosmetics Regulation 1223/2009, Annex VI/27a (UV filters)

Chemical name/INN/XAN
• Titanium dioxide

Name of Common Ingredients Glossary
• Titanium Dioxide [nano]

Maximum concentration in ready for use preparation (finished cosmetic products)
• 25%*
*In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed 25%.

Other conditions
> Not to be used in applications that may lead to exposure of the enduser’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 ≤1 % compared to corresponding non-coated or non-doped reference
- nanoparticles are photostable in the final formulation

Labelling
• For use as a UV filter, must be declared under the INCI name: Titanium dioxide [nano]

COSMOS-Standard

• Listed in Annex IV - Ingredients of mineral origin allowed
• Is authorized in its nano form as a UV filter

USA and Canada

• Titanium Dioxide is a filter approved up to 25%
• When used as a colorant (exempt from certification) in the United States, must be labelled with the INCI name: Titanium Dioxide, and not CI 77891 as in Europe.

CLP Regulation 1272/2008, Annex VI/022-006-002

Applicable from 9 September 2021

Classification
• Carc. 2

Pictogram, Signal Word Codes
• GHS08
• Wng : Warning

Hazard statement Codes
• H351 (inhalation): Suspected of causing cancer by inhalation

Notes
• V: If the substance is to be placed on the market as fibres (with diameter < 3&3 3&μm, length > 3&5 3&μm and aspect ratio ≥ 3&3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.
• W: It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung.
This note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation.
• Note 10: The classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1% or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.

In addition
• The label on the packaging of liquid mixtures containing 1% or more of titanium dioxide particles with aerodynamic diameter equal to or below 10 μm shall bear the statement EUH211: Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.
• The label on the packaging of solid mixtures containing 1% or more of titanium dioxide shall bear the statement EUH212: Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.
• The label on the packaging of liquid and solid mixtures not intended for the general public and not classified as hazardous which are labelled with EUH211 or EUH212, shall bear statement EUH210: Safety data sheet available on request.

Knowledge to date

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References

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