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Dear Colleagues,

APV is delighted to invite you to our conference on “The future Role of Titanium dioxide (E171, TiO2) as an excipient in Pharmaceuticals - Exploring the current and future situation worldwide”.
The conference will focus on hot topics relating to use and replacement of titanium dioxide as a pharmaceutical excipient. The use of TiO2 in medicinal products is under scrutiny, raising concerns among pharmaceutical manufacturers about suitable alternatives.

Titanium dioxide is one of the most commonly used pharmaceutical excipients. It is used very often in solid oral dosage forms (e.g. tablets, hard capsules, soft capsules, granules/powder for oral suspensions) and in semi-solid oral dosage forms (e.g. oral paste) as a white pigment or opacifier. Until now, no equivalent alternative is available that has similar properties of titanium dioxide regarding opacity, whiteness, inertness, protection from UV light and surface texture of the resulting medicines.

On May 6, 2021, the European Food Safety Authority (EFSA) published its “Safety assessment of titanium dioxide (E171) as a food additive” expressing several uncertainties related to TiO2 particles, in particular the shape of TiO2 nanoparticles and the potential of these nanoparticles to accumulate in the body and cause immunotoxicity, inflammation, and neurotoxicity as well as  other potential effects. EFSA did not conclude that there are any actual safety concerns with TiO2, but rather that, due to some data gaps and uncertainties related to genotoxicity, that they could no longer say that E171 is safe based on the precautionary principle. In view of the present opinion, the European Commission legislated that E171 will no longer be approved for use in food as of 7th of August 2022.“ Other regulators in the UK and Canada, after thorough scientific evaluations of all the existing data, have concluded that there are no safety concerns with E171 that currently warrant any changes in the use of TiO2 in foods or pharmaceuticals in those countries.

In European Commission Regulation 2022/63 of 14 January 2022 on the use of TiO2, the Commission states that it will review within three years of the entry into force of this Regulation whether titanium dioxide (E 171) needs to be maintained or removed from the Union list of food additives for exclusive use as a colorant in medicinal products in Part B of Annex II to Regulation (EC) No 1333/2008.The European Medicines Agency (EMA) is to perform an assessment of pharmaceutical uses of TiO2 and the implications of a ban in pharmaceuticals and submit a report to the Commission by April 2024.

The first half day of the conference will focus on the technical use and the role of titanium dioxide in pharmaceutical applications. We will highlight the issues surrounding the use of titanium dioxide and why its use is being questioned. The current legal situation regarding the use of titanium dioxide in pharmaceuticals will be presented from a lawyer’s point of view and we will close the day with a discussion panel on the topics presented.

On the second day we will cover the challenges associated with the replacement of titanium dioxide from different perspectives (OTC/RX producers, EU perspective versus global perspective). We will discuss the regulatory perspectives worldwide and how the impact of replacing TiO2 can be addressed through different types of variations of marketing approvals. Excipient manufacturers are currently developing titanium dioxide-free coating systems and capsules shells with similar pharmaceutical properties to TiO2. Presentations will be given to explain the latest results regarding the safety of TiO2 and also the use of calcium carbonate as one of the possible alternatives. A special session will be focussed on the different perspectives on this topic in other parts of the world, i.e.UK , Canada and USA.

We are looking forward to welcoming you!