Quality and Regulatory Sourcebook
Read the article:
Read the ebook:
Feature|Articles|March 15, 2023
- Pharmaceutical Technology Quality and Regulatory Sourcebook March 2023
- Volume 2023 eBook
- Issue 2
- Pages: 38-41
How Banning Titanium Dioxide Might Impact Pharma
Author(s)David R. Schoneker
The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.
Advertisement
Titanium dioxide (also known as E171 or TiO2) has a long history of safe use across many global industries with several applications in paints, cosmetics, medicines, and food. TiO2 has recently been banned for use in foods and dietary supplements in Europe, and there is a potential that TiO2 could also be banned in pharmaceuticals in the European Union (EU) as early as 2025. The EU is currently evaluating an extension of the E171 ban to pharmaceuticals, and the impact of the potential ban would have serious consequences for the availability of many drugs for European patients.
Background: safety assessment
The European Food Safety Authority (EFSA) re-evaluated the safety of TiO2 (E171), and although there were no studies showing direct interaction of E171 with DNA, EFSA concluded in May 2021 that a genotoxicity concern could not be ruled out and that E171 can no longer be considered safe in food (1). A ban on its use in foods was then quickly proposed by the European Commission (EC).
About the author
David R. Schoneker is the president/owner/consultant at Black Diamond Regulatory Consulting, LLC.
Article details
Pharmaceutical Technology
eBook: Quality and Regulatory
March 2023
Pages: 38-41
Citation
When referring to this article, please cite it as D. Schoneker, "How Banning TiO2 Might Impact Pharma," Pharmaceutical Technology's Quality and Regulatory eBook (March 2023).
Articles in this issue
over 3 years ago
Phase-appropriate Analytical Methodologyover 3 years ago
Pharmacovigilance Automationover 3 years ago
Quality Considerations for the Manufacture of Compounded Drugsover 3 years ago
Overcoming Data Gaps in Pharmacovigilanceover 3 years ago
Points to Consider for Knowledge Management AccelerationAdvertisement
Related to this article
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Pritelivir Shifts Resistant Herpes Care from Intravenous to Oral
2
What the Olanzapine Depot Approval Means for CMC Teams
3
Complying with International Pharmacopoeias
4
PharmTech AI Pulse Check: Availability Bias Threatens AI Regulatory Reviews
5