(52) Titanium Dioxide in Drugs Available on The French Market

Publication Number: 383

Background: Titanium dioxide (TiO2) is an additive which is widely used in products such as cosmetics, drugs and foods for its bleaching and opacifying properties. TiO2 as a food additive has recently gained considerable attention because of its hypothesized harmful effects including carcinogenesis, inflammation or metabolic dysregulation. On October 8th 2021, the Member States of the European Union approved the European Commission's proposal to ban the use of TiO2 as a food additive from July2022. However, the population might still be exposed to TiO2 through drug consumption.

Objectives: We therefore aimed to describe the presence of TiO2 in drugs available on the French market and to estimate the French population exposure to TiO2 through drug consumption.

Methods: We used data from the National Agency for the Safety of Medicines and Health Products (ANSM) to identify all pharmaceutical presentations marketed in France. We used the Theriaque® database to retrieve detailed information on these drugs such as their pharmaceutical form, route of administration or presence of TiO2 or other excipients. The ANSM provided us with data on the corresponding amounts of TiO2 present. We also retrieved the annual number of boxes reimbursed by the French national health insurance system for each pharmaceutical presentation. We described the presence of TiO2 in pharmaceutical drugs marketed in France from 2001 to 2020.

Results: Preliminary results showed that among the 38,322 pharmaceutical presentations available on the French market from 2001 to 2020, 11,698 (30%) contained TiO2. Among the 22,014 pharmaceutical presentations which have been reimbursed at least once from 2001 to 2020, 9280 (42%) contained TiO2, corresponding to 15 437 075 836 reimbursed drug boxes, versus 25 675 546 647 reimbursed drug boxes without TiO2. The median amount of TiO2 present in pharmaceutical presentations was 1.57 mg per box (InterQuartile Range =2.15). Analyses are still in progress and detailed results will be shown during the conference, including (i) the proportion of reimbursed drug boxes containing TiO2, overall, according to their current availability on the market, to the year when placed on the market, to routes of administration, and to pharmaceutical classes (Anatomical Therapeutic Chemical codes), (ii) the number of boxes with and without TiO2 reimbursed per year, by sex and age at reimbursement, and (iii) the cumulative quantity of TiO2 reimbursed in France by year, overall and by pharmaceutical class, route of administration and pharmaceutical form.

Conclusions: TiO2 is widely present in drugs and the health impact of exposure to TiO2 through drug consumption should be evaluated.