Last month the European Food Safety Authority (EFSA) announced that titanium dioxide is no longer considered ‘safe’ for use as a food additive.
Titanium dioxide (aka TiO2 and E171) is frequently used for its effective whitening capabilities and is a popular ingredient in tablets and capsule formulations, as well as food products. It is also used in cosmetics and paints, but the concern for toxicity is only regarding consumables. The EFSA is not banning the use of the substance, but it is going on the record that there no ‘safe amount’ can be established for human consumption.
What Is The Risk?
Previous assessment in 2016 highlighted the need for more research to fill data gaps regarding the safety of Titanium Dioxide. Nanoparticles were of particular interest in this research, as Titanium Dioxide contains at most 50% particles in the nano range (less than 100 nanometers) and exposure to and the effect of nanoparticles on the body is a relatively new area.
As a result of this extensive research, scientists concluded that genotoxicity could not be ruled out, and as such there is no safe amount that can be consumed.
Prof Maged Younes, Chair of EFSA’s expert Panel on Food Additives and Flavourings (FAF), said: “Taking into account all available scientific studies and data, the Panel concluded that titanium dioxide can no longer be considered safe as a food additive. A critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles. After oral ingestion, the absorption of titanium dioxide particles is low, however they can accumulate in the body”.
The European Commission and EU Member States have been informed of the newly revised recommendations for Titanium Dioxide and will consider appropriate regulatory action. This may mean that Titanium Dioxide is restricted or banned in consumables.
What Is Genotoxicity?
If chemicals have an ability to damage DNA in cells, then they can be considered genotoxic. This genotoxicity could have the potential to act as a carcinogenic agent.
What Are The Alternatives?
The team at Chemlink Specialities are ready to help you reformulate to eliminate Titanium Dioxide from your pharmaceutical and nutraceutical products.
We have a variety of whitening ingredients and can recommend the most suitable for your application.
In particular we’d like to provide you with information of two ingredients which show excellent performance as a whitener for tablet and capsule applications.
- galenIQTM 720 can be used as an opacifier
- It has a brightening effect for tableting
- galenIQTM 720 can be combined with calcium carbonate to give a brighter and whiter finish when compared to Titanium Dioxide
- galenIQTM 720 makes formulations taste better
Nippon Talc – Micro ACE P-3
- Nippon Talc has opacifying properties
- Has whiteness of 95%
- Higher surface area leading to lower talc inclusion levels in coating formulations
- Free from asbestos
- No black specks
We can also offer coating polymers, such as: Gohsenol EG (PVA), Pharmacoat (HPMC), and the Polyglycol (PEG) range which can be used as a plasticiser.
Contact our team now to discuss your reformulation requirements.