PharmTech.com Quality and Regulatory Sourcebook March eBook 2023 Pharmaceutical Technology
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viewpoint
TiO
2
alternatives and is collecting information from
the European pharmaceutical industry for submission
to EMA to assist them in understanding the real im-
plications that a ban of E171 would have on pharma-
ceuticals and patients in Europe. Additionally, TDMA
has developed a new science program to perform ad-
ditional studies which should answer any questions
related to TiO
2
safety that regulators might have.
T he goa l of a l l t hese ef for ts is to prov ide EM A
(before they have to provide their report to the EC
in April 2024) with significant information to sup-
port the actual safety of the grades of TiO
2
used in
pharmaceuticals and outline the significant risks to
patient availability of key drug products that would
most definitely occur if the EC were to go for ward
with a ban of TiO
2
for pharmaceutical applications.
For the pharmaceutical industry to avoid an out-
right ban on the use of TiO
2
in pharmaceuticals and
all the associated issues that will arise as a result
(detailed within this article) across the region, it is
imperative for industr y representatives and stake-
holders to act by voicing any concerns to the relevant
regulatory bodies immediately and requesting that
all decisions be based on good science.
References
1. European Food Safet y Authorit y. Safet y Assess-
ment of Titanium Dioxide (E171) as a Food Additive.
EFSA Journal. 2021, Volume 19 (5) page 130.
2. Boyer, I, Unpublished Keller & Heckman Report for the
Titanium Dioxide Manufacturers Association; Review
of EFSA (2021) Safety Assessment of Titanium Di-
oxide (E171) as a Food Additive, EFSA, Sept. 21, 2021.
3. Kirkland, D, et al. A Weight of Evidence Review of
the Genotoxicity of Titanium Dioxide (TiO
2
). Reg-
ulator y Toxicology and Pharmacology. December
2022, Volume 136. ht t ps://w w w.sciencedirect.
com/science/article/pii/S0273230022001507
4. U K Com m i t t e e on Tox ic i t y of C h e m ic a l s i n
Food, Consumer Products and the Environment.
I nter i m Posit ion Paper on Tit a n iu m D iox ide.
Januar y 2022. ht t ps://cot.food.gov.uk/sites/
d e f a u l t / f i l e s / 2 0 2 2 - 0 1 / T i O 2 % 2 0 C O T % 2 0
Interim%20position%20paper.pdf
5. Health Canada. State of Science of Titanium Di-
oxide (TiO2) as a Food Additive. Food Directorate
Health Canada. 2022. https://w w w.canada.ca/
en/ hea lt h-ca n ad a/ser v ices/food-nut r it ion/re-
por ts-publications/titanium-dioxide-food-addi-
tive-science-report.html.
6. FSA NZ. Tit a n iu m Diox ide a s a Food Add it ive.
FSANZ. 2022. https://w w w.foodstandards.gov.
au/consumer/foodtech/Pages/Review-of-titani-
um-dioxide-as-a-food-additive.aspx.
7. TDMA. US FDA Confirms the Safety of Titanium
Dioxide as a Food Additive, TDMA.info. December
2022, https://tdma.info/news/us-fda-confirms-
the-safety-of-titanium-dioxide-as-a-food-additive/
8. Joi nt FAO/ W HO E x p e r t Com m it t e e O n Fo o d
Ad d it ive s. Ni ne t y-s e ve nt h me e t i n g. Nov. 2 ,
2022. https://cdn.who.int/media/docs/default-
source/food-sa fet y/jecfa/ca l l-for-data/jecfa97-
call-for-data.pdf
9. Commission regulation (EU). Annexes II and III
to Regulation (EC) No 1333/2008 of the European
Parliament and of the Council as regards the food
additive titanium dioxide (E171). Publications Of-
fice. 2022/63. 14 January 2022. europa.edu.
10. Hughes, K. Titanium Dioxide: Updates. Chimica
Oggi–Chemistr y Today. 2022, Vol. 40 (6) p. 31.
https://www.teknoscienze.com/Contents/Riviste/
Sfogliatore/CO6_2022/32/
11. Tobyn, M, et al. The Role of Titanium Dioxide (E171)
and the Requirements for Replacement Materials
in Oral Solid Dosage Forms: An IQ Consor tium
Working Group Review. J. Pharm. Sci. 2022. ■
Adare Pharma Solutions .......................................................................... 3
Ascendia Pharmaceuticals ................................................................... 37
Baxter Healthcare Corporation ............................................................ 19
Colbert Packaging .................................................................................. 27
Labvantage Solutions Inc. ..................................................................... 31
Ligand Pharmaceuticals ........................................................................ 17
Natoli Engineering Company, Inc ........................................................... 9
Nelson Laboratories Inc......................................................................... 25
PDA (Parenteral Drug Association) ....................................................... 13
Pharmaceutics International (PII) ......................................................... 23
Renishaw, Inc .......................................................................................... 21
Veltek Associates Inc ............................................................................... 7
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