Titanium dioxide free film coating systems

European Food Safety Authority’s (EFSA) updated assessment on the safety of titanium dioxide as a food additive (published in summer 2021) concludes, that concerns about the genotoxicity of TiO2 particles cannot be excluded. As a result, the European Commission issued Commission Regulation (EU) 2022/63 banning the use of titanium dioxide as a food additive (E171), which will come into force on February 7, 2022, with a six-month transition period until August 7, 2022. This regulatory change particularly affects the food and dietary supplement industry.

To address this issue, BIOGRUND has developed alternative formulations free of titanium dioxide for white and pigmented film coating systems.

With the upcoming reformulations of existing formulations, dietary supplement and OTC product manufacturers have the opportunity to address market trends and consumer demand for natural ingredients. Consumers looking for clean label products that are free of artificial, aluminium, chemical, nanoparticulate or undesired excipients (such as TiO2, talc, palm oil, artificial colors).

Although the pharmaceutical sector is not affected by this regulatory change, developers are already looking to the future and are increasingly trying to dispense with tablet coatings containing titanium dioxide here as well.

“Titanium dioxide free film coating systems – ready-to-use. Designed for easy formulation conversion that meets regulatory requirements and consumer demand. For food supplement and pharmaceutical industry.”

AquaPolish^® ready-to-use systems formulated with substitutes such as calcium carbonates, starches or phosphates offer an easy, fast and reliable TiO₂ alternative by providing the following characteristics:

excellent white brightness
wide color range (customized)
opacity at low weight gain
productivity, due to high solid content
light & moisture protection
product stability

Customized formulation & free choice of coloring stuff (natural/artificial)

ARTICLES ON TIO2 FREE COATINGS ON PHARMAEXCIPENTS.COM

Faster spraying process, lower costs of spraying

The low viscosity of the AquaPolish^® suspension for a white TiO₂ free film coating enables a solid content of minimum 17%. Due to the combination of calcium carbonate and the right amount of stabilizers, a very good opacity can be achieved already at 4% weight gain. An opacity measurement according to the CIELAB method resulted in the following values (maximum is L100): Coating with TiO₂ (100 kg batch) = L97 // Coating TiO₂ free (100 kg batch) = L95. Thus, the opacity is comparable to TiO₂, the surface improves, and the lower viscosity improves the coating process and leads to lower costs.

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TiO2 presentations and panel discussion during ExciPerience 2022

Potential Global Regulatory Impact of the EU E171 Ban on Dietary Supplements and Pharmaceuticals – ExciPerience speech by Dave Schoneker – watch on demand

Experts panel discussion on the future use of Titanium Dioxide (E171) in Pharma – watch on demand

excipients formulation