Tablets Capsules

TC0321

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eye on excipients 42 March/April 2021 Tablets & Capsules Yasemin Koybasi and Chris Venczel Kerry This installment of "Eye on Excipients" discusses the authors' understanding of current titanium dioxide regulations and their impact on tablet film coating. Regulatory agencies are increas- ingly active about ensuring the safety of ingredients used to manufacture the products we consume every day, and this has placed titanium dioxide (TiO 2 ) in the spotlight. TiO 2 is a col- orant used to whiten or opacify a wide range of products. It is authorized as a food additive by the European Union (EU), where it is known by its code on the food additives list, E171. The scientific community evaluated TiO 2 in the 1980s, and since then, regulators have allowed its use at levels not higher than necessary to achieve the intended purpose (quantum satis). TiO 2 is used primarily in food products, particularly products that are popular with children, such as cakes, ice cream, chewing gum, and candy. It is also widely used in non- food products, including plastics, paint, toothpaste, and pharmaceuticals. In the EU, pharmaceutical formulations can only include colorants that are listed in the EU's food additive list. Film coatings for pharmaceutical and nutraceutical tablets have included TiO 2 for decades. However, due to this regulatory scrutiny, manufacturers are increasingly seeking TiO 2 -free film coatings for their products. Developments regarding TiO 2 regulation in the EU In 2015, the EU began to reevaluate all food additives that had received permission prior to 2009. Since TiO 2 had been approved in the 1980s, it was subject to reevaluation. This reevaluation process has been a long journey and is still ongoing. Over the past 6 years, the European Food Safety Authority (EFSA) has issued a number of safety opinions based on studies available at the time, with each opinion concluding that the use of TiO 2 poses no major safety concerns. During this EFSA evaluation, the French government ordered a nation- al-level review on E171 due to concerns raised by consumer health organiza- tions. Several studies performed in French laboratories reported some major health effects, especially in animals that had consumed E171. Stud- ies also showed that E171 crosses the intestine wall in animals to reach other parts of the body, which opened new discussions in France concerning not only TiO 2 but other substances, such as nanomaterials, as well. As a result of these studies, the French health and safety agency said there was not enough evidence to guarantee the safety of E171 and banned its use as a food additive beginning in January 2020. The EFSA reviewed these studies, however, and did not change their conclusion on the safety of E171. The French government later extended the ban to include 2021 and has made it clear that other applica- tions of E171 could be next, including cosmetics and pharmaceuticals, though no official decree has been drafted for those applications yet. In other EU member states, there has been significant demand from cit- izen organizations to follow France's lead and remove E171 from the EU list of permitted food additives, with Over the past 6 years, the European Food Safety Authority (EFSA) has issued a number of safety opinions based on studies available at the time, with each opinion concluding that the use of TiO 2 poses no major safety concerns.

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