Dr. Subhashis Chakraborty, general manager, head - global product management at ACG Capsules discusses the European Commission's decision on titanium dioxide in pharmaceuticals.
1. What does the European Commission’s decision mean in practical terms for pharmaceutical manufacturers in Europe?
ACG Capsules
The Commission’s decision to maintain the use of titanium dioxide (TiO₂) in medicines, based on EMA’s April 2024
Over the past two years, companies had already started exploring TiO₂-free options for new products. But the real challenge was always the existing portfolio, around 91,000 human and 1,600 veterinary medicines in the EU, where TiO₂ serves not just as a colourant, but as a critical opacifier. It ensures uniform appearance, clear identification, and, crucially, protects photosensitive APIs, directly supporting product stability.
Replacing TiO₂ at scale would have been enormously demanding in terms of research, regulatory approvals, and financial resources. EMA’s analysis confirmed that current alternatives fall short across key performance criteria, opacity, colour uniformity, photoprotection, and scalability. Even if viable substitutes were identified, individual reformulations would take 4–6 years, with complete portfolio transitions stretching to 7– 12 years or more. Fewer than 5% of authorised medicines were considered realistically replaceable. Inevitably, this would have led to shortages, product withdrawals, delayed launches, and increased complexity due to EU-specific requirements.
In short, the decision safeguards medicine stability, preserves supply security, and frees resources that can now be better directed toward innovation and patient needs.
2. How do you see this decision impacting global regulatory discussions around titanium dioxide in medicines?
Globally, the EU’s position is likely to serve as an important reference point. The Commission’s decision, grounded in EMA’s conclusion that TiO₂ poses negligible carcinogenic risk in pharmaceutical use, offers both scientific reassurance and regulatory clarity. For international regulators, it highlights the need to balance safety concerns with the practical realities of medicine availability.
This outcome sets an example for other regions to adopt a similar pragmatic approach, recognising that the technical indispensability of TiO₂ today outweighs the risks of a rushed replacement. It also underscores that any move toward alternatives must be gradual, evidence-based, and internationally harmonised to avoid fragmenting medicine supply chains.
Just as importantly, the decision signals to regulatory authorities worldwide that it is time to challenge laws drafted years ago and create room for new technologies and modern scientific methods to reassess excipients. By doing so, authorities can ensure that regulation remains relevant, adaptive, and aligned with both patient safety and technological progress.
3. Can you elaborate on ACG’s specific contributions to the IQ Consortium database, and how you believe it influenced the Commission’s ruling?
ACG’s contribution to the IQ Consortium database was both technical and practical. As one of the world’s leading suppliers of empty hard capsules, ACG was approached by the IQ Consortium to provide both capsules and insights on the concerns raised by European authorities, as well as our perspective on the possibilities and limitations surrounding TiO₂ replacement.
Fortunately, ACG had already undertaken multiple internal studies on the subject. This allowed us to contribute transparent technical data and market experience at a time when the topic was still relatively new to many stakeholders. Beyond knowledge sharing, ACG also supplied tailored empty hard capsules that enabled the Consortium’s research group to conduct detailed experimental studies.
Equally valuable was the continuous technical dialogue we maintained with the IQ Consortium. Regular feedback loops deepened mutual understanding of the scientific and practical challenges, ultimately leading to fact-based, balanced, and logical recommendations for submission to the regulatory agency.
In this way, ACG’s proactive involvement not only strengthened the IQ database but also ensured that the final recommendations reflected both scientific evidence and realworld manufacturing realities, factors that were undoubtedly influential in shaping the Commission’s ruling.
4. How did ACG balance developing TiO₂-free alternatives while also advocating for continued use in medicines?
ACG approached this as a global challenge, working to develop TiO₂-free solutions with regulatory acceptance across both the nutraceutical and pharmaceutical sectors. At the same time, in discussions with pharmaceutical customers, we engaged closely with their R&D, product management, and marketing teams to ensure they fully understood the complexities involved.
We shared our own data, insights on the opportunities and limitations of alternatives, and our expertise in colours and empty hard capsules. This ensured that customer decisions were guided by science and sound rationale—not by market noise—while ACG continued advancing practical TiO₂-free options.
5. With TiO₂ still banned in nutraceuticals, what support or solutions is ACG providing to nutraceutical manufacturers?
ACG has steadily built a complete TiO₂-free capsule portfolio (ACGcaps™ TSafe)— covering white, coloured, and natural-coloured options. We have also gone a step further by developing a range of TiO₂-free printed capsules (printing being an oftenoverlooked element) ensuring capsules can be made entirely TiO₂-free. All alternatives have been designed for broad regulatory acceptance.
In terms of adoption, our TiO₂-free capsules have already been commercialised with leading nutraceutical players worldwide, and we continue to actively support customers with R&D projects and regulatory submissions. While immediate regulatory pressure remains focused on nutraceuticals, we are continuing to expand the portfolio, evaluating more natural colour options to meet rising consumer demand and align with regulatory expectations for cleaner, label-friendly ingredients.
6. Do you expect the nutraceutical ban to eventually be revisited in light of the pharmaceutical exemption?
This seems unlikely in the near future. The pharmaceutical exemption was granted based on detailed EMA reviews, robust data, and the critical need to safeguard medicine availability. Nutraceuticals, however, are regulated differently and are more strongly influenced by precautionary principles and consumer perception.
Therefore, while the pharmaceutical decision sets a clear scientific precedent, it does not automatically translate to nutraceuticals. Unless new evidence emerges or significant regulatory harmonisation becomes a priority, the current ban on TiO₂ in nutraceuticals is expected to remain in place for the foreseeable future.