US consumers recently filed a lawsuit against Mars in a California court, claiming that the content of titanium dioxide in Skittles was too high.
According to an indictment filed by US consumers, titanium dioxide can cause changes in DNA in the human body, damage organs such as the brain, and damage the liver and kidneys. The European Food Safety Agency (EFSA) issued a report in May 2021 that, given all available scientific research and data, titanium dioxide is no longer safe as a food additive.
What is titanium dioxide?
Titanium dioxide, chemical formula TiO2, as an additive code is 171.
Because of its non-toxic, best opacity, best whiteness and brightness, it has been widely used in many fields, such as paint, plastic, rubber, paper, cosmetics, food, medicine and so on.
Titanium dioxide used in pharmaceutical industry
In the pharmaceutical industry, titanium dioxide is often used in pharmaceutical preparations, as a coating agent, colorant and ultraviolet absorbent, for the preparation of coated tablets, pills, granules, capsules and topical preparations.
According to the European Union Trade Association, about 91000 drugs for human use and 800 kinds of veterinary drugs contain titanium dioxide. According to an article published by the European Drug Administration in September 2021 to assess the impact of titanium dioxide on the pharmaceutical industry: it is difficult for the pharmaceutical industry to get rid of titanium dioxide, and this excipient is frequently used in oral solid and semi-solid dosage forms as opaque agents and colorants. such as tablets, capsules, suspensions and so on. It also exists in many essential drugs for human beings, including antibiotics, antidiabetic drugs and so on.
Who is to blame?
It is said that the safety problem of titanium dioxide is not titanium dioxide itself, but a certain proportion of nanometer titanium dioxide. Nano-sized particles may be harmful to human health.
Can titanium dioxide be replaced?
It is not easy to find a replacement for titanium dioxide.
The European Drug Administration has reported that so far, no single substance has been found to provide a combination of properties unique to TiO2 (such as opacity, enhanced contrast, inertia, UV protection and the resulting product smoothness).
Possible alternatives include calcium carbonate, talc, and starch. However, these alternatives have disadvantages (for example, inability to obtain thin enough film, supply chain problems, and the risk of related element impurities).
According to the European Drug Administration, if titanium dioxide is not allowed to add to medicines, it will almost cause a large shortage of drugs and lead to the suspension / withdrawal of these drugs from the EU / European Economic area market. The European Drug Administration's quality working Group (QWP) said there was currently no mechanism for regulators to prioritize products to be reformulated and that the transition period for replacing titanium dioxide would take a decade or more. "each affected pharmaceutical product will require a separate review and evaluation, which will require investigation of alternatives, product reformulation, and collection of new data related to manufacturing, dissolution and stability." The European Drug Administration wrote.
Some enterprises have begun to study alternatives to titanium dioxide. for example, the food company ADM has launched a series of white colorant solutions series Pearl Edge, which aims to replace food-grade titanium dioxide, and Caracom, a manufacturer of thin-film coating systems in the pharmaceutical industry, has launched the Newterfield series of full-formula thin-film coating products designed for nutrition, which clearly states that it does not contain titanium dioxide.
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