TiO2-free capsules are becoming the norm owing to the recent EFSA regulations in Europe. Nutraceutical companies can no longer manufacture empty capsules made using Titanium Dioxide.
Whether you are a consumer or associated with the pharmaceutical industry, you need to know about TiO2 and human consumption. Essentially, the European Food Safety Authority (EFSA) has banned the use of Titanium Dioxide in dietary supplements. In effect since August 2022, EFSA regulation suggests that pharmaceutical and nutraceutical industries cannot use TiO2 (titanium dioxide) additives in food or supplements.
What is the EFSA TiO2 Regulation?
According to the European Food Safety Authority, this is how the nutraceutical and pharmaceutical industries are affected:
TiO2 as a Food Additive
As of August 7, 2022, there is a ban on using Titanium Dioxide as a food additive in food products and dietary supplements. Only TiO2-free capsules are allowed.
TiO2 as a Manufacturing Ingredient in Medicines
Currently, the pharmaceutical industry has received a reprieve. The ESFA ban is only applicable to food and food supplements. The European Commission allows medicine manufacturers to continue selling medicines with Titanium Dioxide. However, they can only do so for three more years, starting from August 2022.
Pharmaceuticals may need to find alternatives or a way to justify their TiO2 use once the period is over.
The European Medicines Agency decided to postpone the ban on Titanium Dioxide in medicines to avoid drug shortages. Nevertheless, the EFSA is regulating the nutraceutical industries strictly.
Titanium Dioxide and Its Use in Empty Capsules
In many products, the natural metal element titanium dioxide is used as a white pigment; it has been typical in food, sunscreen, empty capsules, and more consumable products for years. In the case of empty capsules, tio2 provides the opacity to the capsules.
Titanium Dioxide has several uses in empty capsules. First things first, TiO2 is an inert chemical element that cannot interact with other substances. As such, that concern is out of the question. Additionally, it can tolerate exposure to heat and light.
TiO2 is employed as an opacifier to conceal the empty capsule’s contents. That is not all; it has excellent UV absorption qualities that help shield the capsule’s fill from light-induced deterioration.
Why Are Only TiO2 Free Empty Capsules Allowed Now?
There is currently debate over whether TiO2 is safe for human ingestion. The National Institute of Agronomic Research of France published a study in January 2017 that connected the consumption of titanium dioxide to cellular inflammation events that can result in cancer.
The specific worry raised is that tiny TiO2 particles may be able to get past the body’s defenses in the lungs, liver, and intestines. Due to this study, TiO2 was banned in France, which ultimately resulted in the EFSA’s conclusion.
Interestingly, the European Food Safety Authority opted to ban TiO2 altogether since enough information is available to determine a safe daily dose. Until more evidence is found, nutraceutical markets can only manufacture TiO2-free capsules.
Does Removing Titanium Dioxide Affect Capsule Color?
The short answer is yes; removing TiO2 can change the color of empty capsules. Since the empty capsules are made without Titanium Dioxide, they have an opaque appearance. Even when the fill provides some masking, the capsules become translucent.
For example, Capsuline deals in TiO2-free gelatin capsules and white-colored TiO2-free vegetarian capsules. Capsuline uses calcium carbonate as an opacifier to achieve the white-colored TiO2-free empty capsules. The best part is that we offer Titanium Oxide-free gelatin and vegetarian capsules in any color. Our experts use FDA-approved dyes to manufacture these capsules without adding TiO2.
Moreover, we can manufacture vegetarian capsules using natural colorants like saffron, chlorophyll, carmine, and spirulina. With these ingredients, we do not need to add titanium dioxide or calcium carbonate.
Switching to TiO2-Free Empty May Help Your Brand!
Manufacturing empty capsules without titanium dioxide is a regulatory requirement for nutraceutical companies in the European Union. You can only make TiO2-free capsules for dietary supplements. However, it is also great for cutting cost production, as the ban reduces the usage of an entire ingredient. On the other hand, you can produce products free of synthetic pigments to boost your brand’s clean-label claims.