(CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/215-280- 1, 1317-80-2/215-282-2) (13.05.2024)

The SCCS evaluated the safety of Titanium dioxide for oral cosmetic products based on the EFSA Opinion on genotoxicity concerns for E171. The evaluated TiO2 comprised several grades which differ from the food additive E171 in terms of crystalline forms, particle sizes, coatings, etc., with the exception of 13 uncoated pigmentary grades. The SCCS considered all information (including that evaluated by EFSA, 2021), and considered that the available evidence is not sufficient to exclude the genotoxicity potential of almost all of the types of TiO2 grades used in oral cosmetic products, with the exception of two nano grades (RM09 and RM11) for which the provided genotoxicity data indicate no genotoxicity concern. However more information is needed on the potential uptake and cellular effects of the nano grades in the oral mucosa to consider them safe for use in oral-care products. More experimental data are needed to exclude the genotoxicity potential of the selected representatives of the other grades of TiO2 (both pigmentary and nano) used in oral cosmetic products.