How Banning Titanium Dioxide Might Impact Pharma

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Titanium dioxide (also known as E171 or TiO₂) has a long history of safe use across many global industries with several applications in paints, cosmetics, medicines, and food. TiO₂ has recently been banned for use in foods and dietary supplements in Europe, and there is a potential that TiO₂ could also be banned in pharmaceuticals in the European Union (EU) as early as 2025. The EU is currently evaluating an extension of the E171 ban to pharmaceuticals, and the impact of the potential ban would have serious consequences for the availability of many drugs for European patients.

Background: safety assessment

The European Food Safety Authority (EFSA) re-evaluated the safety of TiO₂ (E171), and although there were no studies showing direct interaction of E171 with DNA, EFSA concluded in May 2021 that a genotoxicity concern could not be ruled out and that E171 can no longer be considered safe in food (1). A ban on its use in foods was then quickly proposed by the European Commission (EC).

Read this article in the Quality and Regulatory Sourcebook 2023

About the author

David R. Schoneker is the president/owner/consultant at Black Diamond Regulatory Consulting, LLC.

Article details

Pharmaceutical Technology
eBook: Quality and Regulatory

March 2023
Pages: 38-41

Citation

When referring to this article, please cite it as D. Schoneker, "How Banning TiO₂ Might Impact Pharma," Pharmaceutical Technology's Quality and Regulatory eBook (March 2023).