On November 23, 2022, the General Court of the European Union reversed the conclusion that titanium dioxide was carcinogenic and released a statement (1,2):

“First, the Commission made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer.”
 
As part of our mission at CRIS we base our safety assessments on the currently available scientific evidence and consider many variables (e.g., study quality, journal of publication, etc.), even if it goes against previous conclusions. Evidence-informed decisions making is critical to ensure that the laws and regulations put into place are for the benefit of the population.
 
The EU General Court maintains that the scientific evidence presented wasn’t the complete picture for the ingredient, “in the present case, the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied.”

Titanium dioxide holds exceptional significance as a white pigment due to its superior scattering capabilities, remarkable chemical stability, and non-toxic nature. Among all white pigments, it surpasses others in terms of its ability to scatter light effectively. Consequently, titanium dioxide stands as the most significant inorganic pigment, accounting for the highest quantity in usage. The majority part of the global production of ilmenite and rutile is dedicated to the production of TiO2 pigments. The remaining portion is utilized for the manufacturing of titanium metal and in the production of welding electrodes.

Titanium dioxide goes into many industrial and consumer products. It makes paper white and bright, it keeps plastics and rubber soft and flexible, and helps remove harmful emissions from car exhaust, among many other uses. In the drug industry, it's a key ingredient in pill capsules and tablet coatings to keep the medicine inside from being affected by sunlight. 

How can food businesses comply with this Regulation?

We've used titanium dioxide safely for decades. However, recently its safety was called into question. 
 
At CRIS, we've explored the safety of titanium dioxide for nearly half a decade, including conducting double-blind research to test the safety of food-grade titanium dioxide (E171). Our study shows that when exposed to food-grade titanium dioxide in normal conditions, research animals did not experience adverse health outcomes.
 
It's important to emphasize that in a National Institutes of Health study, experimental animals were exposed to titanium dioxide in amounts as high as 5% of their diet for a lifetime and showed no evidence of adverse effects. 
 
A handful of studies greatly influenced the decisions made by the European Food Safety Authority (EFSA). Unfortunately, these studies did not consider that titanium dioxide exposure comes from food, not drinking water. Additionally, CRIS researchers could not reproduce the adverse outcomes identified by the studies through typical food ingestion. Regardless, the EFSA banned E171 as a food ingredient and for use in other capacities in the summer of 2022.
 
In 2022, the United States, United Kingdom, and Canada maintained that the scientific evidence supports that titanium dioxide (E171) is safe for humans to use and consume.