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

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

Methods: This study described the presence of TiO in drugs available on the French market and estimated the population exposure to TiO through drug consumption. We used annual drug claim data aggregated at the national level together with data on the TiO 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 TiO. 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 TiO. The median TiO amount in one common dispensing unit was 1.5mg for oral specialties containing TiO. We estimated that the mean exposure to TiO 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 TiO in drugs on the French market. The health impact of exposure to TiO through drug consumption should be evaluated in future epidemiological studies.