use of titanium dioxide in medicine manufacturers

In 2021, the European Food Safety Authority concluded that titanium dioxide is no longer safe in foods due to the same concerns over nanoparticles. As a result, titanium dioxide is now banned as a food additive in the EU. Although studies have shown that the absorption of ingested titanium dioxide is low, evidence suggests that titanium dioxide nanoparticles can accumulate in the body over time. Health Canada deemed it safe in 2022 but noted concerns. Unlike their European counterparts, Canadian officials did not consider studies performed with titanium dioxide nanoparticles alone. 

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  • Titanium dioxide is produced in two main forms. The primary form, comprising over 98 percent of total production, is pigment grade titanium dioxide. The pigmentary form makes use of titanium dioxide’s excellent light-scattering properties in applications that require white opacity and brightness.

  • Titanium dioxide has similar uses in non-food products. It is used in sunscreen as effective protection against UVA/UVB rays from the sun, which creates a physical barrier between the sun’s rays and the skin. It’s also used to whiten paint, paper, plastic, ink, rubber, and cosmetics.

  • On the other hand, the U.S. Food and Drug Administration (FDA) in their Final Administrative Order on Sunscreen Drug Products posted in September 2021 still accepts titanium dioxide up to 25% in the list of Generally Recognized As Safe and Effective (GRASE) in the main document, without further clarification on what kind or size of particles [9]. However, on page 24 (Sunscreen containing nanomaterials) FDA clearly “distinguish nanomaterials from other forms of these ingredients'' (zinc oxide and titanium dioxide) and ask for comments on “any particular nanomaterials that you believe should not be permitted for use in OTC sunscreen products”. To the best of our knowledge, this Agency did not ban the use of nanoparticulate titanium dioxide in any form, even though it is mentioned on page 34 that the anatase form is the more photoactive one, due to the lack of evidence with real sunscreens OTC (over the counter) in vivo. Moreover, other regulations in Latin America (MERCOSUR agreement, 2006) do not state clearly their position on the use of nanoparticulate TiO2NPs [10].