legislation-obligation

Substance Regulatory Obligations

OBL

Titanium dioxide

EC number: 236-675-5

CAS number: 13463-67-7

Last updated: 11/10/2020
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.

CAD - Chemical Agents Directive

CAD - Chemical Agents Directive, Art. 2(b)(i) - Hazardous Agents

This list represents a calculated inventory of substances based on the list of harmonized substances contained in Table 3 of Annex VI to the CLP Regulation (1272/2008/EC). Note that this list is not exhaustive. While the harmonized list covers many hazardous substances, other ones not listed may also meet the classification criteria in accordance with the CLP.

Name CAS
titanium dioxide [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm]
13463-67-7
Cosmetic Products Regulation

Cosmetic Products 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

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 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
EU Ecolabel Regulation

EU Ecolabels - Restrictions for Hazardous Substances/Mixtures

This database contains: (1) the list of hazardous substances harmonized for classification and labeling in EU (i.e. Table 3 of Annex VI to CLP Regulation); and (2) the Candidate List of substances of very high concern (SVHC). The EU Ecolabel may not be awarded to substances or mixtures classified as such. Note that this list is not exhaustive. While the harmonized list covers many hazardous substances, other ones not listed may also meet the classification criteria in accordance with the CLP.

Name CAS Restriction(s) Expressed As Table 3 of Annex VI to CLP EU REACH: List of SVHC Physical form Substance Description  
titanium dioxide
13463-67-7
containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm
yes
powder
Details
Plastic Materials and Articles Regulation

FCM and Articles Regulation, Annex I - Authorised Substances

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
Protection of Pregnant and Breastfeeding Workers Directive

Protection of Pregnant and Breastfeeding Workers Directive, Annex I+II

This list contains substances to which pregnant workers and workers who have recently given birth or are breastfeeding may not be exposed. This is only a partial list; employers are obliged to prevent the exposure of these workers to any agents that may cause adverse health effect for either mother or child. This list is generated from hazardous substances listed in Directive 92/85/EEC and from table 3.2 of Annex VI of the CLP.

Name CAS CLP (1272/2008) CMRs ECCAR Directive 2004/37/EC EU_BA PREGW Notes  
titanium dioxide [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm]
13463-67-7
Carc. 2
Details
Protection of Young People Directive

Physical, Biological and Chemical Agents & Processes and Work

This list contains biological and chemical agents, in accordance with Art. 7 and points 2 and 3 of the Annex to Directive 94/33/EC, to which young persons (under 18 years of age) may not be exposed at the workplace. The database represents a non-exhaustive list of such substances based on: 1) agents of risk groups 3 and 4 under Directive 2000/54/EC; 2) Table 3 of Annex VI to the CLP Regulation; 3) and Annex I of Directive 2004/37/EC.

Name CAS EC_YOUNG ECCAR Directive 2004/37/EC EU CLP (1272/2008) EU_BA Directive 2000/54/EC Notes  
titanium dioxide [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm]
13463-67-7
Carc. 2
Details
Safety and/or Health Signs at Work Directive

Workplace Signs - minimum requirements & signs on containers and pipes

This directive requires employers to ensure proper signage is posted in areas where hazards cannot be avoided or reduced. The annexes to this directive provide detailed information about the minimum requirements for all safety and health signs. According to the annexes to the directive, storage areas and containers containing chemical substances or mixtures that are classified as hazardous according to the CLP Regulation (1272/2008/EC) must be marked and/or labeled.

Name EC Number CAS Index Sustance Description Danger Symbols Restriction Physical form  
titanium dioxide
236-675-5
13463-67-7
022-006-002
Health hazard
containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm
powder
Details
WFD - Waste Framework Directive

Waste Framework Directive, Annex III - Waste - Hazardous Properties

This database contains substances that have been assigned hazard property (HP) waste codes 1-15, as defined in terms of the hazard class & category, hazard (H) statement, and/or concentration limits provided in Annex III of the Waste Framework Directive (2008/98/EC). The classifications of the substances listed in the database are based on their harmonized classifications per Table 3 of Annex VI to the CLP Regulation (1272/2008/EC).

Name EC Number CAS EU CLP (1272/2008) HP Code Index
titanium dioxide [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm]
236-675-5
13463-67-7
Carc. 2
HP7 Carcinogenic: waste which induces cancer or increases its incidence.
022-006-002

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