The Potential for a Ban on TiO2 (E171) use in Pharmaceuticals
There has been written a lot about Ti02 in the last years and the industry has reacted. Nevertheless I think some of the information in this Technical Newsletter by Fuji Chemicals is still quite interesting and important to understand a potential ban of TiO2 in pharmaceteuticals. The most important in my opinion is the potential drug shortages arising from reformulation and / or decision to take well-known drugs from the market if reformulation does not make sense based on cost vs market volumes. The full newsletter can be accessed here. Here some outtakes of the main messages:
POTENTIAL TiO2 BAN - STATUS AND IMPLICATIONS
The EU considers banning TiO2 in pharmaceuticals, potentially impacting over 91,000 drug products and causing shortages.
Titanium dioxide, also known as E171 or TiO2, has long been used across the cosmetics, medicine, and food industries without safety concerns. The EU has recently imposed a ban on the use of TiO2 in food and dietary supplements and foresees a potential ban in pharmaceuticals pending a decision until early 2025.
Several other regulatory bodies such as the USFDA, Health Canada, UK Food Standards Agency, and FSANZ (Australia and New Zealand) have critically reviewed the data and concluded no safety concerns with the use of TiO2:?
- Currently the “precautionary principle†based ban is seemingly limited solely to the EU and those territories who simply follow their legislation.
- The scientific opinion as discussed by IPEC indicates that there is no scientific merit in banning the substance, hence they suggest that it must be political.
TiO2 serves unique functions in pharmaceuticals:
- Opacity: Protects tablets and capsules from UV light, ensuring stability and potency.
- Protection: Shields printed information from wear and tear.
- No alternatives: No other excipient currently offers these combined functionalities.
领英推è
?BAN CONCERNS:
- Drug shortages: Even assuming sufficient resources, reformulating each affected drug would take 30-60 months, potentially leading to shortages.
- High costs: Reformulation involves significant investments in new studies, registration, and approval.
- Unnecessary risk: Several regulatory agencies, including US FDA, Health Canada, JECFA (2023), and Food Safety Australia/New Zealand (2022), deem TiO2 safe at relevant doses.
DIFFICULTIES WITH REPLACING TiO2:
- No suitable alternatives: Finding replacements with similar opacity, whitening power, and regulatory approval is challenging.
- Unique properties: TiO2 offers unmatched attributes like inertness, high melting point, and specific color change under laser irradiation, crucial for functionality.
FUTURE PROSPECTS
The present scenario on the potential ban on TiO2 by the EU remains dubious. Basis the most recent findings published in the PQRI position paper, there is a probability of the ban coming through in a limited manner: it may be restricted to new product development and may not warrant replacement in existing formulations owing to significant costs, drug shortages, and medicine accessibility issues highlighted earlier in the discussion. This still opens doors to evaluation of more alternatives to TiO2.
#tio2 #excipients #drugdelivery
Product Development | Natural/Pharma | Formulation | Improvement | Product life cycle
10 个月That makes sense. When the scientific reasoning related to safety is clear and sufficient, I think the alternatives and the ways to implement them will follow. A rational approach by the regulator will also be needed, especially regarding the urgency and timeline. The material and method, as the substitutions might not be 100% identical, but they still work.
Pharma CEO @CarboHyde | Innovative Cyclodextrin-based Solutions
11 个月Based on my limited information about TiO2, I think it will be banned sooner or later for sure from pharma too, and probably that is for the best
We are having our Midweek Talk on coating just now. You can join the event via the stream: https://www.glatt.com/midweek-talk/
President/Owner/Regulatory & Quality Consultant - Black Diamond Regulatory Consulting, LLC
11 个月I would like to thank Fuji Chemicals for publishing this technical newsletter which states the facts fairly clearly. I just wanted to emphasize and clarify the point that is mentioned concerning drug shortage possibilities. In the publication it talks about the possibility of drug shortages due to the long time that it would take to try to reformulate drug products, but I would like to make it clear that this is not the only thing that WILL cause drug shortages in Europe if the EU were to ban the use of TiO2 in pharma applications. We all need to understand that many (probably thousands) of drug would probably not even be reformulated at all to remove TiO2, especially since TiO2 will continue to be approved for use in most of the rest of the world, because there would be no economic justification for many pharma companies to reformulate these products. This would especially relate to older drugs with low margins, certain generic and OTC drugs, drugs for special populations like pediatrics, geriatrics and orphan drugs. In reality, many pharma companies would just withdraw these products from the EU market if a ban on TiO2 were imposed on pharma products which is not based on any credible safety concern which is the case here!
Senior Executive & Scientist – Certified Board Member - Life Science – R&D Leader – Change Projects – Drive innovation & Commercialise Products – Cross-functional Expert – Project & Portfolio Management – Pharmaceuticals
11 个月Thanks Philippe, your opinion and voice on this matter counts. I'm glad that we at Fuji, together with Pharmaexcipients and the greater scientific community can voice our opinions on this issue that has such vast importance to the pharmaceutical industry as a whole.