Exposure assessment of titanium dioxide via drugs available on the French market: A nationwide descriptive study.

Abstract

Purpose: Based on potential adverse health effects including genotoxicity concerns, the European Union banned titanium dioxide (TiO₂) as a food additive in 2022, but food-grade TiO₂ can still be used in pharmaceutical products.

Methods: This study described the presence of TiO₂ in drugs available on the French market and estimated the population exposure to TiO₂ through drug consumption. We used annual drug claim data aggregated at the national level together with data on the TiO₂ content of pharmaceutical products available on the French market in 2001-2020.

Results: Of the 17 171 pharmaceutical specialties identified on the French market between 2001 and 2020, 38% contained TiO₂. That figure reached 95% for capsules, 92% for film-coated tablets, 74% for coated tablets and 66% for soft capsules. Only 1% of non-oral specialties contained TiO₂. The median TiO₂ amount in one common dispensing unit was 1.5mg for oral specialties containing TiO₂. We estimated that the mean exposure to TiO₂ per inhabitant through the consumption of reimbursed drugs between 2012 and 2020 was 1.71mg per day, with women (1.81mg/d) slightly more exposed than men (1.54mg/d) and people older than 59 years (4.00mg/d) much more exposed than younger people (1.24 and 0.21mg/d for 20-59 and<20 years old individuals, respectively).

Conclusion: This study highlights a widespread presence of TiO₂ in drugs on the French market. The health impact of exposure to TiO₂ through drug consumption should be evaluated in future epidemiological studies.