Lithopone

History

However, some experts and food regulators in other countries disagree – pointing to potential, serious health consequences and rising concerns about the additive. Starting August 7, for example, the use of titanium dioxide in food will be banned in the European Union.

Additionally, the committee noted that the available data did not provide convincing evidence of genotoxicity for titanium dioxide as a food additive, but recognized the limitations in current methodologies with respect to the testing of poorly soluble particulate materials. Although there were uncertainties in the genotoxicity data, the experts took into account the fact that the additive was not carcinogenic in adequately conducted two-year studies in mice and rats at doses of up to 7,500 mg/kg BW per day for mice, and 2,500 mg/kg BW per day for rats, the highest doses tested. There was also no evidence of reproductive or developmental toxicity in studies in rats at doses up to 1,000 mg/kg BW per day, the highest doses tested.  

Titanium dioxide is used in an enormous range of food products, which can feel jarring when looking at some of its other uses.

Because of the uncertainty of the impacts of nanoparticles, Made Safe exercises the precautionary principle, meaning we avoid nanoparticles until more extensive scientific testing proves their safety.

Above 20%, it is recommended to replace 1 kg TiO2 with 1.3 kg of Lithopone 30%.  

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.

3. Regulatory Compliance It is crucial for suppliers to adhere to industry regulations, especially in sectors like food, pharmaceuticals, and cosmetics. Reliable suppliers will ensure their products meet relevant regulatory standards, providing proper documentation and certifications.

Titanium dioxide can form several different shapes, which have different properties. Some shapes can be converted to nanomaterials. Micronized TiO2 (also called “nano” or “nanoparticles”) was introduced in the early 1990s.Nanotechnology and micronization both refer to the practice of creating very small particles sizes of a given material. “Nanoparticles” usually refers to particles smaller than 100 nanometers; a nanometer is 1/1 billionth of a meter. At these small sizes, and at low concentrations, titanium dioxide appears transparent, allowing for effective sunscreens that do not appear white.

Faber argued there hasn't been enough change in these federal regulations in the decades following the FDA's approval of titanium dioxide – especially as others increasingly point to potential health consequences.

Among the raw materials for coating production, titanium dioxide is more ideal, followed by lithopone. The covering power of lithopone is only that of titanium dioxide, and the price of lithopone is much lower than that of titanium dioxide, so lithopone still occupies a large market share.

In their role as risk managers, the European Commission and Member States will now reflect on EFSA’s scientific advice and decide upon any appropriate regulatory measures or advice for consumers.

≤0.3

Titanium dioxide is often listed in the ingredients list on the product label when used in home, beauty and personal care products.