Amsterdam: Pharmaceutical industry groups are working to submit comments to the European Medicines Agency (EMA) to oppose a proposed ban on the use of titanium dioxide (TiO2) in Europe. The European Commission is expected to make a final decision on the ban in February 2025, which if enacted would take effect in early 2026.
These actions were prompted by a scientific opinion from the European Food Safety Authority (EFSA) in May 2021 that concluded that TiO2 (also known as E 171) is not considered safe when used as a food additive. Shortly after, in January 2022, the European Commission published a regulation removing the authorization for TiO2 as a food additive and opening up the possibility of extending the ban to pharmaceuticals.
Experts recently described to Focus some of the behind-the-scenes discussions about addressing this ban and reiterated concerns on the high cost of reformulating drugs with TiO2-free alternatives. They also stated that European regulators’ concerns about TiO2 in food and pharmaceuticals is not shared by other health authorities.
The Commission, in its 2022 regulation, said it would “review the necessity to maintain titanium dioxide (E 171) or otherwise delete it from the Union list of food additives for exclusive use as a colour in medicinal products within three years.” The review will be informed by an assessment by the European Medicines Agency (EMA) that is expected to be completed by 1 April 2024.
At this year’s Excipient World conference in National Harbor, MD, panelists said that the ban would have a grave impact and lead to drug shortages.
Looking at the big picture, Hughes said the EFSA 2021 opinion lacked a scientific justification to support the ban. “When you look at it, the EFSA opinion 2021, it did not identify any specific safety issues. There was a lack of data around genotoxicity. They could not prove it was harmful, but they could not prove it was safe,” he said.
As such, the European Commission invoked the “precautionary principle” and proposed to ban the ingredient altogether rather than risk its continued use in pharmaceuticals, Hughes explained. He added that other regulators, including the UK and Japan “disagreed with the EFSA report. They disagreed with the conclusions and the precautionary approach that the EU used.”
Canada, Australia, New Zealand and the US have stated that TiO2 as a food additive does not pose a risk to human health, according to Hughes.
Schoneker agreed that the European Commission is an outlier in this area. “The bottom line is that there is no scientific explanation to support the ban, it is a farce,” he said. “There is absolutely no scientific justification for them taking this position,” he said.
Schoneker added that European regulators are unnecessarily scaring the public. “The Japanese conducted a similar study and found no safety problems with TiO2,” he said.
