The European Commission prohibits its use as an additive, so brands need to have a new 100% reliable option for the products that will be manufactured from now on.
NutraResearch is working for all their customers to reformulate their products to ensure a 100% reliable alternative to the use of titanium dioxide (TiO2). This January, the European Commission has banned its use as a food additive (known as E171) and, by extension, its presence in food supplements.
Titanium dioxide has been used for decades in food, pastry products, cosmetic creams and medicines, among many other products, due to its whitening properties and its ability to generate textures. However, an investigation by the European Food Safety Authority (EFSA) published in May 2021 indicates that titanium dioxide can no longer be considered safe as a food additive because, although it has not been able to establish the toxic potential of this ingredient, neither been able to rule out genotoxicity. Genotoxicity is the ability of a chemical to damage the genetic material of cells and has associated carcinogenic effects. As it has not been possible to establish a safe level for the daily intake of titanium dioxide and, thus, not being certain that it is a safe additive, the EC has decided to withdraw it.
Titanium dioxide is used in capsules and in coated tablets, to ensure opacity. For the time being, its use is still allowed in medicine tablets, but not in food supplement tablets.
NutraResearch moves forward with solutions already available to quickly answer to customer and market needs
NutraResearch’s R&D department has been working for more than a year to find the best formulations to replace the use of titanium dioxide in tablet coatings. That is why we already have multiple solutions that adapt to different products. “We offer new options that allow us to maintain a similar color and coating barrier”, explains the R&D director, Dr. Albert Sala. A task that, even though, is not easy: “The solution for each product is different”, explains Sala, since the change of titanium dioxide in the coating for an alternative has an impact on stability of the product. The behavior of each product may be different depending on its formulation and the rest of the components that compose it. This is how, in the event of using a new coating that is not suitable for the rest of the elements, it can change color, become wet, crack… To ensure that the formulation is correct, it is necessary to carry out stability tests, so that, once in the market there is a total guarantee that the product will perform well, maintaining its safety and quality. These stability tests have a duration of six months.
Precisely to make it easier for firms to adapt to the new standard, the European Commission has approved a six-month moratorium for its compliance, which means that from August on, it will no longer be possible to produce products that include titanium dioxide. All the product that is already on the market before that month can be sold while supplies last. This fact offers sufficient margin to carry out the new reformulations and the necessary stability studies. Various firms, however, have already gone ahead and have been working with NutraResearch on the new formulations. That is why this February, products with the new coatings will be released on the market.
Ask us here for more information if you need the best alternative to replace titanium dioxide in your tablets.