legislation-obligation
legislation-obligation
Substance Regulatory Obligations
OBL
Rutile (TiO2)
EC number: 215-282-2
CAS number: 1317-80-2
Last updated: 13/11/2021
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
Cosmetic Products Regulation, Annex III - Restricted Substances
This list contains substances whose use in cosmetic products in the European Union is banned, except under certain conditions as indicated in Annex III. The list specifies the field of application or use, maximum allowable concentration limits in finished products, and any additional limitations.
| Ref No. | Substance Identification | Restrictions | Warning Label | Notes | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | EC Number | CAS | Product type, body parts | Function(s) | Maximum Threshold | Minimum Threshold | Restriction(s) | Qualifier(s) | Expressed As | ||||
|
321 |
Rutile (TiO2) |
215-282-2 |
1317-80-2 |
Face products in loose powder form |
25 % |
Only in the pigmentary form |
In powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm |
Applies from 1 October 2021 |
Details | ||||
|
321 |
Rutile (TiO2) |
215-282-2 |
1317-80-2 |
General use hair aerosol spray products |
1.4 % |
Only in the pigmentary form For general consumers |
In powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm |
Applies from 1 October 2021 |
Details | ||||
|
321 |
Rutile (TiO2) |
215-282-2 |
1317-80-2 |
Professional use hair aerosol spray products |
1.1 % |
Only in the pigmentary form For professional use only |
In powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm |
Applies from 1 October 2021 |
Details | ||||
|
321 |
Rutile (TiO2) |
215-282-2 |
1317-80-2 |
Cosmetic products other than face products in loose powder form and hair aerosol spray products |
Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation |
In powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm |
Applies from 1 October 2021 |
Details | |||||
Cosmetic Products 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 labelling 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 |
Rutile (TiO2) |
215-282-2 |
1317-80-2 |
All cosmetic products |
UV Filter |
25 % |
Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm: (a) to be used in compliance with Annex III, No [321] (b) for cosmetic products other than face products in loose powder form and hair aerosol spray products the maximum concentration in ready for use preparation provided in column (g) of this entry applies |
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 in column g |
Details | ||||
|
27a |
Rutile (TiO2) |
215-282-2 |
1317-80-2 |
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 | ||