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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].
A few non-dietary studies have reported adverse effects in the gastrointestinal tract of laboratory animals given food-grade TiO2. However, these same effects were not seen when the same or higher doses of food-grade TiO2 were administered in the animals' diet. Dietary studies best reflect how humans are exposed to TiO2 from food. Thus, the Food Directorate placed the most emphasis on the results of these studies in the state of the science report.
However, since it’s photosensitive — meaning it can stimulate free radical production — it’s usually coated in silica or alumina to prevent potential cell damage without reducing its UV-protective properties (7Trusted Source).
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EFSA’s scientific advice will be used by risk managers (the European Commission, Member States) to inform any decisions they take on possible regulatory actions.
White Titanium Dioxide Pigment Factory A Pillar of Modern Industrial Production
