Issue link: https://www.e-digitaleditions.com/i/1349974
Tablets & Capsules March/April 2021 43 comprehensive review of all available scientific evidence to evaluate whether to add TiO 2 to its list of prioritized chemicals as a potential cause of devel- opmental or reproductive toxicity. Once a chemical is finalized on this list, manufacturers of products containing the chemical must provide warnings on product labels within one year. TiO 2 -free alternatives for tablet film coatings In light of all these regulatory devel- opments, suppliers of pharmaceutical and nutraceutical film coatings are actively developing alternative coating formulas in case the TiO 2 ban spreads beyond France. A film coating formula has three major components: the polymer, the plasticizer, and pigments. The main characteristics that tablet manufac- turers look for in a tablet film coating are brand identity, tablet core pro- tection, regulatory acceptability, and whiteness or opacity. TiO 2 is widely accepted as the best whitener/opacifier in the industry and, until recently, has enjoyed wide regulatory acceptance. While its primary use is to provide a bright white color, it is often used in combination with various pigments to create a wide range of colors. These can range from soft pastels to brilliant, bright colors, where TiO 2 provides an important opacifier function. Often, multivitamin tablet cores are dark or specked. Adding TiO 2 to a film coating increases its opacity, covering the cores and preventing the dark col- ors from bleeding through the coating. Typically, about 3 percent weight gain of the film coating is sufficient, but this more than 80,000 people across Europe signing a petition supporting the French ban. Last year, the European Commis- sion (EC) proposed revising the E171 specifications to include additional particle-size parameters based on data provided by TiO 2 manufacturers. The proposal concluded that a specification of more than 100 nanometers for the median minimal external dimension, equivalent to less than 50 percent of the number of constituent particles with a median minimal external dimension below 100 nanometers, as measured by electron microscopy, should be inserted in the current specifications. However, the European Parlia- ment rejected this proposal with a large majority of votes and has called on the EC to apply the precautionary principle and remove E171 from the EU list of permitted food additives. Parliament not only objected to the proposed specification, but also called for removing E171 from the food addi- tive list because members of Parliament are particularly concerned about chil- dren being exposed to the additive. The EU Commission recently informed the World Trade Organi- zation (WTO) that it has withdrawn the proposal, and for now, the current specification will be maintained. The next EFSA opinion is expected by March 2021 and will be based on data provided recently by TiO 2 manu- facturers. We expect this to be EFSA's final decision. TiO 2 regulation in the US According to the US FDA, tita- nium dioxide may be safely used in foodstuffs as a colorant. The FDA has set a limit of 1 percent, meaning that in the US, food products, including dietary supplements, cannot contain more than 1 percent titanium dioxide. For nonfood uses, TiO 2 is generally recognized as safe. In 2011, California placed TiO 2 onto its Proposition 65 list of chemicals known to the state to cause cancer or reproductive toxicity. This requires warnings on products containing the substance. California's official envi- ronmental health hazard assessment (OEHHA) committee has begun a Photo 1: Comparison of uncoated multivitamins (left) and multivitamins coated at 4.5 percent weight gain with a TiO 2 -free coating with calcium carbonate pigment (SheffCoat TF 30748443, Kerry) (right). www.tabletscapsules.com Visit our website now to watch videos on: Packaging, capsule lling equipment, coating, dedusters, excipients, pneumatic conveying, tablet presses, tooling, and more.