Some consumer advocacy groups and health agencies — particularly, those at the Environmental Working Group — have been pushing federal officers at the Food and Drug Administration (FDA) to reconsider their existing rules on the additive, which is commonly found in processed snacks and sweets.

1. Lithopone is used as an inert pigment in paints, inks and cosmetics.

The safety of the food additive E 171 was re-evaluated by the EFSA ANS Panel in 2016 in the frame of Regulation (EU) No 257/2010, as part of the re-evaluation programme for food additives authorised in the EU before 20 January 2009.  

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 is used a food colour (E171) and, as with all food colours, its technological function is to make food more visually appealing, to give colour to food that would otherwise be colourless, or to restore the original appearance of food. Titanium dioxide is also present in cosmetics, paints, and medicines.

In a small study published in the European Journal of Nutrition in 2020, researchers examined the effects of several food additives, including titanium dioxide, along with artificial sweeteners and cleaning products by testing the fecal samples of 13 people. Titanium dioxide was among the samples that “induced significant shifts in microbiome community structure.”  The growth of the bacterium species belonging to C. leptum, which has been shown to decrease in patients with inflammatory bowel disease, “significantly decreased in the presence of … titanium dioxide” among other additives and sweeteners tested.

TiO₂ is also used in oral pharmaceutical formulations, and the Pharmaceutical Excipients handbook considers nano-sized TiO₂ a non-irritant and non-toxic excipient. Despite the fact that TiO₂ submicron- and nano-sized particles are widely used as food and pharmaceutical additives, information on their toxicity and distribution upon oral exposure is very limited.

The California plaintiff is apparently not the only one concerned about titanium dioxide. The European Union recently banned its use citing concerns about serious health consequences.

What exactly is titanium dioxide?

Europe