The European Scientific Committee on Consumer Safety (SCCS) evaluated information on genotoxicity of titanium dioxide used in cosmetic products. This was triggered by previous similar concerns for food additive E 171 (titanium dioxide, TiO2). For almost all the 84 different grades evaluated, the SCCS concluded that the available evidence is insufficient to rule out their genotoxicity potential. This is consistent with the earlier European Food Safety Authority (EFSA) opinion on E 171. SCCS sees a need for more experimental data, especially on products like toothpastes, which consumers use every day. SCCS also highlights that quality of studies should be improved to reduce uncertainty in assessment.

Why does SCCS come with this advice on titanium dioxide?

In March 2021, the European Food Safety Authority (EFSA) re-evaluated food additive E 171 (titanium dioxide, TiO2) and concluded that they could not exclude the possibility that E 171 is genotoxic. As a result, the EU European Union (European Union ) banned E 171 from being used in food in January 2022. However, several countries outside of Europe have different views on the safety of E 171. Considering the discussions on TiO2 in food, the European Commission asked the Scientific Committee on Consumer Safety (SCCS) to assess the safety of TiO2 in orally-used cosmetic products. In addition, the Committee was asked to critically re-assess the genotoxicity after inhalation exposure, as described in the SCCS opinion(PDF) from 2020.

Genotoxicity potential cannot be excluded for most TiO2 grades evaluated

The SCCS evaluated information on a wide range of TiO2 material types (44 pigmentary and 40 nano grades) used in cosmetic products. Except for 13 uncoated pigmentary grades, the evaluated TiO2 materials differed from food additive E 171 in crystalline forms, particle sizes and coatings.

After evaluating all the information, including that assessed by EFSA in 2021, the SCCS considered that the evidence available is insufficient to rule out the potential genotoxicity of most of the TiO2 grades. Based on the provided data, only two grades, RM09 and RM11, showed no genotoxicity concern.

What does this advice mean for exposure to TiO2 via other routes?

The SCCS noted that ingesting cosmetic product ingredients is unintended and incidental. Therefore, ingestion of TiO2 from these products is expected to be far lower than from TiO2 used as a food additive. In addition, the SCCS previously established that the currently available scientific evidence supports an overall lack of skin absorption(PDF) of TiO2 particles from cosmetic products. Furthermore, the Cosmetics Regulation already restricts the use of the nanoform of TiO2 in cosmetic products that may lead to exposure by inhalation(PDF). The SCCS evaluation on oral TiO2 exposure from cosmetic products does not provide a reason to change previous SCCS opinions on the other exposure routes for TiO2 in cosmetic products.

More information is needed to assess the safety of nanosized TiO2 in oral care products

The evaluation by the SCCS of ingested TiO2 from cosmetic products revealed several shortcomings in the safety assessment. For nano-grade TiO2, more information is needed on its uptake and cellular effects in the oral mucosa. In addition, some pigmentary grade TiO2 products contain a considerable proportion of particles in the nanosize scale, which should be considered in their safety assessment. Furthermore, there is a need for genotoxicity studies on a larger variety of TiO2 grades, carried out using valid protocols and appropriate testing guidelines. Overall, further investigation is needed to assess the risk to the consumer from long-term repeated exposure to nanosized TiO2.

Reflections by RIVM

The SCCS evaluation confirms EFSA’s conclusion that the genotoxicity potential of TiO2 cannot be excluded. This SCCS Advice demonstrates the complexity of the issue. Various TiO2 grades meet the E 171 specifications, yet other TiO2 grades on the market differ in physicochemical properties, such as having very small (< 30 nm) particles or a coating. It is difficult to determine if the wealth of available genotoxicity data on TiO2 is relevant for all the materials used in cosmetic products.

Out of the 84 grades evaluated by SCCS, only 2 indicated no genotoxicity concern. The characterisation data provided to SCCS do not allow clarity on if and how these 2 grades differ from the other grades. This hampers the potential use of read-across approaches where data from one grade may be used for other grades as well. Clarity on the differences could provide clarity on the potential of forming groups of grades, and subsequently the need for further genotoxicity studies for such groups.

For oral exposures, further identification is needed of the grades used in specific toothpaste products.

In case lack of clarity on these issues remains, a consequence could be that certain grades of TiO2 will be banned from cosmetic products due to an inconclusive opinion on their safety. This will then be in line with earlier Scientific Advice by SCCS and the subsequent implementation in regulation by the European Commission.