FDA’s response

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.”

What titanium dioxide is really emblematic of ... is the failure of FDA to look back at these old decisions and ask whether its decisions that were made in this case ... 56 years ago (in the 1966 approval) still hold up, he said.

There are numerous manufacturers of titanium dioxide; the largest include Delaware-based Chemours (a spin-off of DuPont Chemical), Texas-based Kronos, and China-based Lomon Billions Group, all of which manufacture pigments for use in products like paints, coatings, and plastics. UK-based Venator is a major supplier of titanium dioxide used in food and cosmetics, along with paints, paper, plastic, and more. As a pigment, it is called Pigment White 6 (PW6), titanium white, or CI 77891. As a food additive, it is known as E171.