Ingredient

CI 77891

Name / description

CI 77891; Titanium Dioxide


Function(s) of this ingredient in cosmetic products

COLORANT

Colours cosmetic products, skin, nails and / or hair


Origin

mineral


Occurrence in cosmetics

As a white pigment in many decorative cosmetics


Occurrence in other products

Titanium dioxide is widely used as the white pigment eg in paints, coatings and plastics


Background information on use in cosmetics

Titanium dioxide is a white inorganic (mineral) solid. In nature, titanium dioxide is widespread in the form of the minerals rutile and ilmenite. Titanium dioxide is chemically and thermally very stable (inert) and insoluble. Colourants ensure an appealing appearance of the cosmetic product and serve for the embellishment of the skin and hair. The most frequently used colourants are synthetic; only a few natural substances are available. For colourants, the applicable INCI names are in most cases the so-called Colour Index Numbers, the "CI Numbers".


Information on safe use

According to the EC Cosmetics Regulation [Regulation (EC) No. 1223/2009], which applies to the entire EU market, colourants are defined as substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of physical light. Annex IV of the Regulation defines the substances which may be used as colourants in cosmetic products. In this positive list of colourants maximum concentrations are defined in part for the use of these substances in cosmetic products as well as the permitted areas of application. Hair colourants are currently still separately regulated in the EC Cosmetics legislation. In future it is planned to include them also into Annex IV. Colourants are examined prior to their authorisation in Annex IV selectively for their toxicological safety and subjected to extensive tests. The manufacturers must prove the health safety in extensive scientific studies. Moreover, the approved colorants are reassessed and the list is updated accordingly in line with new scientific findings and in the event of suspected adverse events evident from market surveillance.


Why are we talking about it?

Titanium dioxide is suspected of being carcinogenic by inhalation and genotoxic by the oral route. The facts: Studies have shown that titanium dioxide is potentially carcinogenic by the respiratory route (inhalation) (2). This potential is not specific to it, as it has also been found for mineral particles of the same size. However, epidemiological data have not shown any link between exposure to titanium dioxide and the development of lung cancers in humans (3). The mechanism involved is specific to the lung area. This is why titanium dioxide has been classified at European level as a possible carcinogen by inhalation (category 2). Therefore, titanium dioxide in powder form with small particle size is not used in cosmetic products that are likely to be inhaled, such as sprays (5). The use of titanium dioxide on the skin is considered to be safe, as its skin absorption is low. Last, studies have shown the absence of carcinogenic potential by the skin route (4). Key points to take away: The use of titanium dioxide in cosmetic products, by the skin route and therefore without respiratory or oral exposure, is considered safe at the authorised concentrations (1). Sources: (1) Regulation (EC) No 1223/2009; Annex VI (2) Opinion of the Committee for Risk Assessment (RAC), 2017: https://echa.europa.eu/documents/10162/682fac9f-5b01-86d3-2f70-3d40277a53c2 (3) International Agency for Research on Cancer (IARC), 2006: https://monographs.iarc.fr/wp-content/uploads/2018/06/mono93.pdf (4) CLH report: Proposal for harmonised classification and labelling, 2016: https://echa.europa.eu/documents/10162/594bf0e6-8789-4499-b9ba-59752f4eafab (5) Opinion of the Scientific Committee on Consumer Safety on TiO2: https://ec.europa.eu/health/system/files/2021-11/sccs_o_238.pdf


Further information

Concerning titanium dioxide as a UV filter, see the INCI names TITANIUM DIOXIDE and TITANIUM DIOXIDE (NANO)


Belongs to the following substance groups


Regulating cosmetics

Cosmetics Ingredients are subject to regulation. Please note, different regulations may apply to cosmetic ingredients outside the EU.

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