Pharmaceutical Technology - September 2021


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8 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m Regulatory Oversight T itanium dioxide (TiO 2 ) is widely used for adding opacity and brightness in many products, including food, cosmetics, and sunscreen, as well as in nutraceuticals and pharmaceu- tical drug products, where it is used as a pigment in some uncoated tablet formulations, gelatin capsules, and tablet coatings. A May 2021 evaluation from the European Food Safety Authority (EFSA), which declared that TiO 2 is unsafe for food products, alarmed other industries that rely on the ingredient. EFSA, which had been reviewing TiO 2 as a food coloring (E171 in EFSA's list of additives), concluded that "a concern for genotoxicity of TiO 2 particles cannot be ruled out. Based on this concern, EFSA's experts no longer consider titanium dioxide safe when used as a food additive. This means that an Acceptable Daily Intake (ADI) cannot be established for E171" (1). The agency noted that its evalu- ation relates only to food products, and its advice will be used by risk managers, such as the European Commission and member states, for any possible regulatory action (1). Companies and industry groups in other regions and markets, however, are taking note. PharmaLex reported that three associations (Medicines for Europe, the European Federation of Pharmaceutical Industries and Asso- ciations, and the Association of the European Self-Care Industry) spoke in favor of the need for TiO 2 in pharmaceuticals and suggested that the European Medicines Agency (EMA) should conduct an im- pact assessment prior to making any decision about TiO 2 in drug products (2). The associations estimated that more than 90% of oral dosage forms contain TiO 2 , and that reformulating drug products Considering Titanium Dioxide Regulatory Changes Jennifer Markarian The European Food Safety Authority's evaluation of risk of titanium dioxide in food products raises implications for use of the pigment in drug product formulations. Alternatives are available for evaluation, but reformulation could be costly and time- consuming. K ATERYNA _KON - STOCK.ADOBE.COM

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