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EU Scientific Committee Warns of Potential Genotoxicity of Titanium Dioxide in Oral Cosmetics

Recently, The Scientific Committee on Consumer Safety (SCCS) has raised potential genotoxicity concerns regarding the use of titanium dioxide (TiO2) in oral cosmetic products. In its final opinion, the SCCS reviewed data on 44 pigmentary and 40 nano grades of TiO2 used in these products, concluding that the evidence is insufficient to definitively rule out genotoxic risks for most TiO2 grades.

The assessment identified that while two specific nano grades, RM09 and RM11, did not show genotoxicity concerns, further information is needed on their absorption and cellular effects in the oral mucosa. The committee underscored the importance of understanding TiO2 nanoparticle absorption, retention, and potential adverse effects in the buccal mucosa, particularly since cosmetics are not intended for ingestion, thus accidental ingestion would occur in much smaller quantities compared to food.

The SCCS distinguished between the cosmetic pigmentary grades of TiO2 and the food additive E171, noting differences in crystalline forms, particle sizes, and coatings, with 13 uncoated pigmentary grades being equivalent to E171. Given that nanoparticles can constitute over 50% of the particle count in these pigmentary grades, their presence in cosmetics warrants careful consideration when evaluating safety.

In addition to oral exposure, the SCCS also reviewed previous assessments on inhalation and dermal exposure to TiO2. The committee affirmed that the safety conclusions for dermal application remain unchanged for the newly evaluated TiO2 grades and coatings, but new data on dermal absorption are necessary for TiO2 types not yet covered by the EU Cosmetics Regulation.

Furthermore, the SCCS upheld its earlier opinions on TiO2 safety for inhalation, as outlined in Annex VI of the Cosmetics Regulation, which restricts the use of TiO2 nanoform in applications that could lead to inhalation exposure.

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