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38 Pharmaceutical Technology ® Quality and Regulatory Sourcebook March eBook 2023 PharmTech.com AB-7272 - STOCK.ADOBE.COM T itanium dioxide (also known as E171 or TiO 2 ) has a long history of safe use across many global industries with several applications in paints, cosmetics, medicines, and food. TiO 2 has recently been banned for use in foods and di- etary supplements in Europe, and there is a potential that TiO 2 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-eval- uated the safety of TiO 2 (E171), and although there were no studies showing direct interaction of E171 with DNA, EFSA concluded in May 2021 that a geno- toxicity 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). Toxicology experts from Keller and Heckman con- ducted a thorough review of the EFSA safety assess- ment at the request of the Titanium Dioxide Manufac- turers Association (TDMA). This group of independent experts concluded that EFSA based its evaluation ex- clusively on genotoxicity tests of materials that are not representative of the food additive E171, using meth- ods of exposing test animals that are not representa- tive of human exposures. The opinion did not consider differences in manufacturing processes of different test nanomaterials or differences in the composition and other properties of the test nanomaterials, com- pared with E171. These materials are very different. The experts found that, in its weight of evidence (WoE) How Banning TiO 2 Might Impact Pharma David R. Schoneker is the president/owner/ consultant at Black Diamond Regulatory Consulting, LLC. The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.