Potential EU ban on Titanium Dioxide (TiO2) and the effects on consumer & drug products

Recently there was a proposal by the EU to ban titanium dioxide (TiO2) in medicines. If this ban is enacted, millions of patients and tens of thousands of marketed medications in Europe would be affected. If this ban is enacted by the EU, all products formulated with TiO2 would be unable to be distributed and marketed in the EU.

The Functions of Titanium Dioxide

Titanium dioxide is the naturally occurring oxide of titanium. It’s a white powder that’s widely used as a whitening agent, UV filter, and thickener in many consumer products and pharmaceuticals. Because it is naturally bright and reflective, it’s added give these products a cleaner color. Since it protects skin from both UVA and UVB radiation, titanium dioxide has been used in sunscreens for decades. And because it’s less irritating than UV absorbing chemicals like oxybenzone, it’s often the active ingredient in sunscreens for babies and those with sensitive skin.

The Safety Debate

There have been ongoing debates regarding the safety of titanium dioxide in foods and medicines. It seems that the EU has conflicting views with the rest of the word regarding the safety risks associated with this excipient. Many companies are already reformulating their products without TiO2 based on such safety concerns and direction of the EU proposed ban.

The Bottom Line

If existing pharmaceutical product formulations are changed, these reformulated products would in turn have to be re-validated and re-verified for all possible properties because of variation submissions. This would cause bottlenecks in the EU, as well as in the United States. In the United States, this would cause a greater backlog for the FDA.

On the other hand, it could also be argued that TiO2 can be replaced “easily” by calcium carbonates or magnesium oxides.

If titanium dioxide should be banned by the EU, additional excipients like magnesium stearate, silicon oxide or microcrystalline cellulose, would also be in question. If these excipients would also be banned in a similar process as the proposed TiO2 ban, the pharmaceutical industry could face major difficulties and severe drug shortages.

The topic of the necessity of a full ban of TiO2 in pharmaceutical formulations remains controversial. It will be interesting to see in which direction the regulating authorities in the various countries will lean towards.