Titanium Dioxide
Also known as Titanium dioxide, TiO2, Titania, CI 77891
“EU SCCS says: restricted.”
Titanium dioxide (TiO2; CAS 13463-67-7) is a widely used mineral UV filter and white pigment. The EU SCCS opinion SCCS/1617/20 (adopted October 2020) evaluated pigmentary TiO2 specifically in the context of inhalation exposure, concluding it is not safe at up to 25% in aerosol hair spray products but is safe at up to 25% in loose powder face make-up for general consumers. Dermal-route applications (sunscreens, foundations) are broadly considered safe based on evidence that TiO2 does not penetrate beyond the stratum corneum to viable skin cells. Peer-reviewed literature (PMIDs 31588611, 24198489, 21642632) consistently finds negligible dermal absorption in intact and compromised skin; the primary concern is the inhalation route due to TiO2's classification as a Carcinogen Category 2 by inhalation under EU Regulation (EC) No. 1272/2008.
Effective broad-spectrum UV filter (UVA and UVB protection) used in sunscreens, foundations, and BB creams at concentrations up to 25%; EU Annex VI entry 27 permits use as UV filter at up to 25%
White pigment (CI 77891) providing opacity, whiteness, and coverage in makeup products including foundations, concealers, and powders
Physical UV filter with no known systemic absorption through intact skin at cosmetic use concentrations; does not penetrate beyond stratum corneum under normal use conditions
Non-sensitizing and non-irritating to skin; SCCS considers nano-form TiO2 non-sensitizing and mild/non-irritant for dermal applications
- · Photocatalytic activity of nano-form TiO2 can generate reactive oxygen species (ROS) upon UV exposure; coatings (silica, alumina, dimethicone) are used in cosmetic grades to suppress this activity
Inhalation route: TiO2 is classified as a Carcinogen Category 2 by inhalation under EU Regulation (EC) No. 1272/2008; aerosol and spray cosmetic products containing TiO2 are restricted by the EU, and SCCS/1617/20 found aerosol hair spray use at 25% unsafe for both consumers and hairdressers
Nano-form TiO2 in inhalation-risk products: SCCS opinions SCCS/1516/13 (2013) and SCCS/1583/17 (2017) addressed nano-form TiO2 as a UV filter in sunscreens, concluding nano TiO2 does not pose a risk via dermal absorption but flagging inhalation risk in spray/powder products
France's 2020 national measures (pre-ban on E171 food additive) were directed at oral/ingestion route of nano TiO2 in food, not cosmetic use; this concern does not directly apply to topical cosmetic products but adds to the broader regulatory attention on TiO2 particle safety
SCCS/1661/23 (2024) raised genotoxicity concerns for TiO2 grades used in oral cosmetic products (toothpastes, lip products), noting insufficient evidence to exclude genotoxicity potential for most grades except two specific nano grades (RM09, RM11)
SCCS Opinion on Titanium dioxide (TiO2) used in cosmetic products that lead to exposure by inhalation — SCCS/1617/20, adopted 6 October 2020
“On the basis of safety assessment, the SCCS is of the opinion that the use of pigmentary titanium dioxide (TiO2) up to a maximum concentration of 25% in a typical hair styling aerosol spray product is not safe for either general consumers or hairdressers. The safety assessment has shown that the use of pigmentary TiO2 in loose powder up to a maximum concentration of 25% in a typical face make-up application is safe for the general consumer.”— SCCS/1617/20 Final Opinion, p. 4 (Abstract section)