For years, titanium dioxide was considered a safe and widely used ingredient in supplements. However, the European Union's decision to ban it in food products and supplements in 2022 has raised numerous questions about the substance's safety. What exactly is titanium dioxide, what are its properties, and can it actually be harmful to health?
What is titanium dioxide?
Titanium dioxide (TiO₂) is notorganica chemical compound that occurs in nature as the mineral rutile or anatase. Due to its high refractive index, titanium dioxide tablets It gives them a perfectly white, opaque color. It is a thermally stable substance, resistant to UV radiation, and practically insoluble in water. Due to these characteristics, it has been used not only in pharmaceuticals but also in cosmetics, paints, and food products. In the supplement industry titanium dioxide in supplements facilitated quality control – thanks to the uniform color of the tablets, it was possible to quickly detect production defects. When planning a new product formula, available raw materials for dietary supplementsto ensure appropriate technological and visual properties. It is at this stage that a decision is made as to whether a compound such as TiO₂ will be necessary.
Application of titanium dioxide
Application titanium dioxide in pharmacy and supplements was due to its ability to mask the undesirable color of active ingredients. It also made the tablet easier to swallow when it was part of the coating. This is why titanium dioxide in supplements and medicines was so popular – it provided aesthetics, durability, and stability. In the pharmaceutical industry titanium oxide acted as a protective layer, shielding the active ingredient from light and moisture. It was found in a variety of products – from vitamins to painkillers. Due to new regulations, companies offering contract production of dietary supplements had to develop alternative coloring solutions. Appropriate technology and appropriate experience in packaging of dietary supplements allow you to maintain the aesthetics of your products despite the lack of traditional titanium pigments.
Titanium dioxide and the European Union
The issue of regulation titanium dioxide in medicines and supplements became famous after the European Union issued Regulation 2022/63, which withdrew titanium dioxide (E171) from the list of permitted food additives. According to the regulations, from August 7, 2022, no food or supplement can contain TiO₂. However, its use in pharmaceuticals is still permitted because E172 in medicines was not subject to a full ban. The reason for this decision was the results of analyses by the European Food Safety Authority, which could not guarantee that the substance did not exhibit genotoxic properties. Although direct toxicity has not been proven, the precautionary principle applies. For companies operating in the supplement industry, this means that technical documentation must be modified. Each new product requires procedures such as notification of dietary supplements. It is also necessary dietary supplement registration– everyone, because the composition and excipients used must comply with current regulations.
Review harmful effects of titanium dioxide is not clear. Animal studies have shown that high doses of TiO₂ particles can cause oxidative stress and inflammation. However, the level of exposure in humans is incomparably lower. Despite this, the European Food Safety Authority concluded that a genotoxic risk could not be completely ruled out, so a preventive ban was decided on its use in food. From the industry's perspective, this decision meant the need to develop new formulations. Manufacturers had to analyze, how to produce a dietary supplement without TiO₂, while maintaining the aesthetics and durability of the product. This is sometimes associated with another the cost of producing dietary supplements, however, compliance with the law and consumer safety are a priority.
Titanium dioxide in supplements
Although titanium dioxide in supplements was withdrawn from the market, its previous technological role was important. This compound gave the tablets shine and uniform color, and also protected the active ingredients from oxidation. Currently, substitutes of plant or mineral origin are used, which do not show any suspicion of toxicity. For manufacturers offering the creation own brand of supplements These changes mean new challenges in recipe design and production process optimization. In turn, in the technological phase packaging of dietary supplements and quality control must take into account the increased sensitivity of products to light. Modern laboratories are developing new coating solutions that preserve the aesthetics of supplements without the use of titanium dioxide, while also meeting strict pharmaceutical standards.
Is titanium dioxide in medicines harmful?
Question, Is titanium dioxide in medicines harmful?, remains open, but there is currently no clear evidence indicating its toxicity in the permitted amounts. In pharmaceuticals, it serves only an auxiliary function and does not affect the effectiveness of treatment. Currently, it can be used, among others, in hard capsules and other modern formulas that it offers capsule manufacturer Softgel (soft capsules). Thanks to thorough testing, the risk of negative health effects from TiO₂ in medications is minimal, allowing its continued use in certain medicinal products.
Titanium Dioxide – Summary
Summarizing, titanium dioxide is a substance with a long history of use in the food and pharmaceutical industries. Although it was considered safe for years, recent research has prompted the European Union to ban its use in supplements and food. Before taking a drug or supplement, it is worth checking whether manufacturer of soft capsules or other forms of using this ingredient. Consumers are increasingly interested in, what is the difference between a medicine and a supplement, because it is the legal and technological differences that determine the acceptability of ingredients such as TiO₂. Modern production plants implementing processes blistering and advanced packaging technologies, today focus on safe dye alternatives. Although the discussion about harmful effects of titanium dioxide is still ongoing, modern regulations and technological progress allow for maintaining a balance between consumer safety and the quality and durability of supplements and medicines.
