legislation-obligation

Substance Regulatory Obligations

OBL

Titanium dioxide

EC number: 236-675-5

CAS number: 13463-67-7

Last updated: 11/03/2020
ECHA Legislation Regulatory Obligations

Regulatory obligations may exist for this substance under the legislations under ECHA’s remit or for which ECHA has delegated tasks (i.e. REACH, CLP, BPR, PIC, CAD / CMD, WFD, and POPs). Please check the substance Infocard.

Cosmetic Products Regulation

EU. Cosmetics Regulation Annex IV, Allowed Colorants

This list contains coloring agents allowed for use in cosmetic products marketed in the European Union. The list indicates the approved fields for application, including whether or not the colorant is permitted for use in products applied near the eye or on mucous membranes, or in products intended to come in contact with skin.

Ref No. Substance Identification Conditions Notes  
Name EC Number CAS Colour index (CI) Number Colour Physical form Product type, body parts Restriction(s) Maximum Threshold Expressed As Function(s)
143
Titanium dioxide
236-675-5
13463-67-7
77891
White
All cosmetic products
Purity criteria as set out in Commission Directive 95/45/EC (E 171)
Colorant
For use as a UV-Filter, see Annex VI, No. 27
Details

EU. Cosmetics Regulation Annex VI, Allowed UV Filters

This list contains substances designated as UV filters which cosmetic products marketed in the European Union may contain. The list contains concentration limits and additional restrictions, as well as labeling requirements for some substances.

Ref No. Substance Identification Conditions Warning Label Notes  
Name EC Number CAS Common Ingredients Physical form Product type, body parts Function(s) Maximum Threshold Restriction(s) Expressed As
27
Titanium dioxide
236-675-5
13463-67-7
All cosmetic products
UV Filter
25 %
For use other than as a colorant, see Annex IV, No. 143
In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given
Details
27a
Titanium dioxide
236-675-5
13463-67-7
Nano
All cosmetic products
UV Filter
25 %
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 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
For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips.
For use as a colorant, see Annex IV, No. 143
In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g
Details
Plastic Materials and Articles Regulation

EU. Com. Reg. No 10/2011 on plastic materials in contact with food

Also referred to as the Plastics Implementation Measure (PIM), this Regulation provides the Union List of monomers and other substances authorized in the manufacture of food contact plastics.

Name CAS FCM No Ref No. Additive or PPA Use as monomer/macromolecule FRF applicable SML (mg/kg) SML(T) Group Restriction No SML(T) Group FCM substances SML(T) (mg/kg) Restriction(s) Notes on verification Notes Physical form Group name Expressed As  
titanium dioxide
13463-67-7
610
93440
yes
no
no
Details

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