KEVIN HUGHES
Regulatory Affairs and Quality Assurance, Manager, Colorcon Limited, Dartford, United Kingdom

Abstract

This article provides some insight on the following question: why is Europe on a course that will require the removal of titanium dioxide (TiO2) from 91,000 medicines in the EU at the estimated cost of €32bn, with potentially significant delays to the approval of new medicinal products and the potential to impact the availability of medicines in the EU?
An insight into this topic can be found in the Interim Position Paper from the Committee on Toxicology (COT) (1) which provides a useful summary of the titanium dioxide story over the last 6 years.

THE CURRENT SITUATION
In May 2021, the European Food Safety Authority (EFSA) published an Opinion that titanium dioxide (TiO2) (E171) could “no longer be considered safe when used as a food additive” (2), and a ban on its use in foods was quickly proposed. On review, the conclusion of the EFSA Opinion is not based on any hazard being proven, rather it is due to insufficient data to rule out a potential risk from genotoxicity, despite the requested animal studies showing no adverse effects at high doses. In January 2022 legislation was published requiring the removal of E171 from foods; as no immediate health risk was identified a transition period of 6 months is permitted, ending in August 2022. As consumption of foods is unrestricted, intake levels of titanium dioxide by consumers cannot be accurately predicted, using the precautionary principle it is perhaps understandable that a ban on foods is applied. The Committee on Toxicology (COT) advising the Food Standards Agency in the UK does not agree with the EFSA conclusions based on the science (1) and Health Canada (3) and Food Standards Australia and New Zealand (FSANZ) (4) have recently published t ...