Titanium dioxide in medicines

TiO2 in medicines is safe

As a pure mineral, TiO2 meets the most stringent requirements governing the safety of medicines, including those set by the European pharmacopoeia, Japanese pharmacopoeia and US pharmacopoeia. For decades, TiO2 has built up an impressive safety record within the pharmaceutical industry.

Despite the large body of existing science and data confirming the safety of TiO2, concerns have recently been raised about the safety of TiO2 in medicines because on 14 January 2022 the European Commission issued a Regulation removing TiO2 from the approved list of food additives.

This action was based on a European Food Safety Authority (EFSA) opinion of May 2021 on the food grade of TiO2 called E171, which is also used in pharmaceuticals. EFSA did not identify any immediate health concerns linked to E171 or raise any concerns about the use of TiO2 in medicines but took a precautionary approach.

While the EFSA opinion only concerns TiO2 used in food, the European Commission stated in the Regulation adopted on 14 January 2022 that it will consult with the European Medicines Agency (EMA) and review the safety of TiO2  used in medications over the next three years.

Considering the growing scientific consensus over the safety of TiO2 in food, it is important that new scientific evaluations are taken into consideration to avoid unnecessary changes to medicines.

The uncertainties raised by EFSA have been recently addressed by Health Canada, the Canadian government’s health policy department. Health Canada carried out a comprehensive review of the available science and new data generated after the EFSA opinion, concluding that E171 is safe for human consumption. The UK’s Food Standard Agency (FSA) reached the same conclusions earlier this year.

Find more about the Health Canada and UK FSA opinion.

TiO2 in medicines in the EU

While the EFSA opinion only concerns TiO2 used in food, the European Commission stated in the Regulation adopted on 14 January 2022 that it will consult with the European Medicines Agency (EMA) and review the safety of TiO used in medications over the next three years.

Considering the growing scientific consensus over the safety of TiOin food, the TDMA calls on the European Commission to trigger a critical re-examination of the EFSA 2021 opinion. The conclusions of international scientific authorities should be duly taken into consideration in the EU assessment of TiO2’s safety and its continued use in pharmaceuticals.

How important is TiO2­ in medicines?

In an opinion issued on 8 September 2021, the European Medicines Agency (EMA) concluded that TiO2 cannot be replaced without a negative impact on the quality and quantity of medicines in the EU. The EMA opinion stresses that a requirement to replace TiO2 in medicines will almost certainly cause “significant medicines shortages” in the EU market, with “major implications for patients”.

The EMA points out that, because of the time and costs involved in the reformulation of a substantial volume of products, any requirement to replace TiO2 in medicines will almost certainly cause shortages but also withdrawals from the market of medicinal products. Products such as pediatric and orphan health maintenance (like blood pressure) medicines would be likely the most impacted due to the millions of people who rely on these drugs.

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