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HomeScientific advice on titanium dioxide (TiO2) (CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/215-280- 1, 1317-80-2/215-282-2)
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From the provided information, the SCCS has noted that the titanium dioxide (TiO2) materials evaluated in this Scientific Advice belong to a wide range of grades (44 pigmentary and 40 nano grades) used in cosmetic products. The pigmentary grades differ from the food additive E171 in terms of crystalline forms, particle sizes, coatings, etc., with the exception of 13 uncoated pigmentary grades that can be considered as equivalent to E171. Having considered all the information (including that evaluated by EFSA, 2021), the SCCS considers 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. The only exception are two nano grades (RM09 and RM11) for which the provided genotoxicity data indicate no genotoxicity concern. More information is, however, 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 from studies carried out under valid protocols and appropriate testing guidelines to exclude the genotoxicity potential of the selected representatives of the other grades of TiO2 (both pigmentary and nano) used in oral cosmetic products. It is worth highlighting that the SCCS approach to risk assessment of TiO2 ingredients in orally-used cosmetic products is slightly different from that of EFSA. This is because cosmetic products are not meant to be ingested orally, and any ingestion via the oral route can only be unintended and incidental. Keeping this in mind, the amounts of orally-ingested cosmetic ingredients can only be expected to be far lower than the amounts ingested when a TiO2 material is used as a food additive, which is consumed via intake of the food products. For the SCCS, the potential absorption/retention, translocation and adverse effects of nanoparticles in the buccal mucosa are therefore important considerations for safety evaluation. The SCCS recommends that safety assessment of the pigmentary TiO2 grades used in cosmetics should also take account of the fact that some of them contain a sizeable proportion of the particles in the nano size scale – some over 50% (in terms of particle number, median constituent particle size).
- Published:
- Corporate author(s): Directorate-General for Health and Food Safety (European Commission)
- Themes: Consumers' health , Scientific and technical research
- Subject: aerosol , chemical compound , consumer protection , cosmetic product , health risk , oxide , regulation (EU) , toxic substance
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| ISSN 1831-4767 | ISBN 978-92-68-28876-4 | DOI 10.2875/1117743 | Catalogue number EW-01-25-088-EN-N |
- Released on EU publications website:
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