E171 and pharmaceuticals – Bibliography

Public or para-public organizations

In French

• Recitals 14 to 18 and Article 3 of European Regulation 2022/63, European Commission, January 2022
• TiO2 in medicines, Compte rendu du Comité Scientifique Permanent Sécurité et Qualité des Médicaments, Formation Restreinte Qualité Pharmaceutique, December 2, 2021, ANSM, June 2022
• Titanium dioxide, Compte rendu du GT20 sur la Sécurité non clinique du 21 février 2017, ANSM, February 2018

In English

• Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products ANSM, Frontiers in Public Health, March 2023
• Replacement/removal of titanium dioxide (TiO2) in medicines. Technical and procedural guidance EMA, July 2022
• Final feedback from European Medicine Agency (EMA) to the EU Commission request to evaluate the impact of the removal of titanium dioxide from the list of authorised food additives on medicinal products, EMA, September 2021
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Research (selection of synthetic articles and literature reviews)

In French

• Risks associated with the ingestion of titanium dioxide nanoparticles, AVICENN @VeilleNanos (regularly updated fact sheet)
• Titanium dioxide in the pharmaceutical industry: Identity card, regulatory status, toxicity studies and titanium dioxide-free alternatives, Edouard Garçon, Thesis for the State Diploma of Doctor of Pharmacy, 2021
• Should titanium dioxide be banned in medicines?, M2 thesis, Mines Paris PSL Research University, Les controverses de Mines Paris, January 2024
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In English

• Risks associated with the ingestion of titanium dioxide nanoparticles, AVICENN @VeilleNanos (regularly updated fact sheet)
• The Implications of the EU Ban on Titanium Dioxide: A Comprehensive Review of Safety Concerns and Alternatives, Pokharkar V et al, Annales Pharmaceutiques Françaises, 2024
• Exposure assessment of titanium dioxide via drugs available on the French market: A nationwide descriptive study, Cairat M, Huybrechts I, Fournier A, Therapies, 79(6) : 718-729, November – December 2024
• …

Media, patient or consumer associations, …

• Nanos and medicines, AVICENN @VeilleNanos (regularly updated)
• The European Commission called to account for its inaction, Que Choisir, juin 2025
• Titanium dioxide in medicines: what is Europe doing?, 60 millions de consommateurs, juin 2025
• E171 in pharmaceuticals: when will the European Commission end its silence?, AVICENN @VeilleNanos, juin 2025
• Titanium dioxyde in pharmaceuticals must be banned, petition on MesOpinions.com, March 2025
• E171 : all about titanium dioxide and its effects on health, Doctissimo, October 2024
• Titanium dioxide still not banned in medicines, Viva, March 2024
• Titanium dioxide and medicines: all black or all white?Le Moniteur des pharmacies, March 23, 2024
• TiO2: awareness-raising efforts are helping to speed up the process of eliminating it!L’information dentaire, January 17, 2024
• E171 in medicines: indispensable, really?, S!lence, n°528, January 2024
• Bad in food, good in health products?Prescrire, January 1, 2024
• Nanoparticles: why so many drugs still contain titanium dioxide, L’OBS, November 24, 2023
• Towards a total ban on titanium dioxide?60 millions de consommateurs, July 20, 2023
• Titanium dioxide in medicines: what are the health risks?Le Mag de la santé, France 5, June 2023
• Nanos in our medicines, Kali Magazine, January-February 2022 (pages 36-39)
• Banning titanium dioxide – The European Medicines Agency puts the brakes on, Que Choisir, 2021
• Will the additive E171 also be banned from the composition of medicines?Le Temps, 2021
• Questions from cancer patients on the Ligue contre le cancer forum about E171 in medicines
  • Questions about oral chemotherapy, 2021
  • Questions about complement – lung, thyroid and respiratory cancers, 2020
• Why not ban E171 in medicines?La Nouvelle République, January 2020
• “Removing E171 from drugs would be extremely burdensome according to pharma union,” Rose Up, August 28, 2019
• Titanium dioxide banned in confectionery from 2020, not toothpaste or medicines, Le Monde, April 2019
• Médicaments : des nanos dans l’Efferalgan et le Nurofen, 60 Millions de consommateurs, March 22, 2018
• Additive E171: whiter than white but still not clean, Fondation ARC, March 2017
• E171 dye: Medicines too!Que Choisir, February 4, 2017
• E171, a not-so-white additive!Rose Up, February 3, 2017
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Pharmaceutical laboratories and federations and/or titanium dioxide manufacturers

• Industry’s perspective on challenges assessing the in vivo impact of removing titanium dioxide (TiO2) from drug products, Abend A et al, (Merck, Pfizer, etc.), Journal of Pharmaceutical Sciences, 113(11): 3119-3122, November 2024
• Titanium Dioxide (E171 grade) and the Search for Replacement Opacifiers and Colorants: Supplier Readiness Survey, Case Studies and Regulatory Perspective, Hancock B et al (Pfizer, Merck, GSK, AstraZeneca, Eli Lilly, Bristol Myers Squibb), Journal of Pharmaceutical Sciences, May 2024
• Challenges and Opportunities to Formulate Nutraceutical Tablets Without Titanium Dioxide, Colorcon, March 2024
• Use of titanium dioxide as excipient in human and veterinary medicines and identification of alternatives, Industry feedback to GWP experts/EMA questions, EFPIA, TiO2 Alternatives Consortium, Medicines for Europe, AESGP, Animal Health Europe, Access Vetmed, IPEC Europe, EUCOPE, February 2024
• The Potential for a Ban on TiO2 (E171) use in Pharmaceuticals and the Impact on Patients and the Industry, IPEC USA, webinar, February 2024
• Is there a Case for Banning Titanium Dioxide (E171) in Pharmaceuticals?Position Paper, PQRI, January 2024
• Pharma groups fight proposed ban on titanium dioxide in Europe, RAPS, November 27, 2023
• Comments sent by several federations working with the pharmaceutical industry, in response to the FDA consultation following thelegal petition filed by several associations calling for a ban on E171 in the USA:
  • Comments Regarding Filing of Color Additive Petition from Environmental Defense Fund, et al; Request to Revoke Color Additive Listing for Use of Titanium Dioxide in Food, Consumer Healthcare Products Association (CHPA), August 2023
  • IPEC-Americas,
  • IQ Consortium,
  • Black Diamond Regulatory Consulting,
  • …
• TiO2 EU Regulations and Pharmaceuticals: What to KnowCOLORCON, date ? (accessed October 2023) > video
• Industry is Urging EMA to Increase its Focus on Medicine Impact of EU Food, Chemical, and Environmental Legislation, July 21, 2023
• Titanium dioxide (E171) and its role in formulation, Mike Tobyn (Bristol Myers Squibb), Jonathan Kaye (GSK), David Harris (MSD) and Jason Melnick (Eli Lilly), European Pharmaceutical Review European Pharmaceutical Review, Volume 28, Issue 03, June 2023
• Why would the EU want to ban titanium dioxide in pharmaceutical products? What would be the potential impact on patients? David R. Schoneker President, Black Diamond Regulatory Consulting, LLC, J. Excipients and Food Chem. 13 (4), December 2022
• The Role of Titanium Dioxide (E171) and the Requirements for Replacement Materials in Oral Solid Dosage Forms, Blundell, R., et. al., J Pharm Sci., November 2022
• What do 681 Drug Tablets and 4,080 Skittles Have in Common?, Lyle D. Burgoon, Ph.D., ATS, Toxic Truth, Raptor Pharm & Tox, Ltd. September 2022
• Possible Adverse Effects of Food Additive E171 (Titanium Dioxide) Related to Particle Specific Human Toxicity, Including the Immune System, Pharma Excipients, August 2021
• Use of titanium dioxide as excipient in human medicines – Industry feedback to QWP experts/EMA questions, AESGP, EFPIA , Medicines for Europe, July 2021
• #RienACacher -T. Borel: Titanium dioxide not yet labelled as an excipient with a notorious effect? LEEM, July 2021
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