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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].
But a chemical’s safety when it’s used externally is not always the same as when it’s ingested. Different uses of the same ingredient may cause very different health outcomes.
In the meantime, the chemical factories of Continental Europe, principally in Germany, Austria and Belgium, had taken hold of the novelty and under the collective name of lithopone or lithophone, by numerous processes, produced various grades of the pigment, branding the respective qualities as red seal, green seal, yellow seal, blue seal, etc., or selling them under some fancy name. Of this we shall speak later on. The crusade against the use of white lead in the various countries of Continental Europe, assisted the manufacturers, to a very great extent, in marketing their products, not only to industrial concerns, as has been the case in this country, until recently, but to the general painting trade. Up to 1889 the imports into this country were comparatively small. At that time one of the largest concerns manufacturing oilcloth and linoleum in the State of New Jersey began to import and use Charlton white. Shortly after that other oilcloth manufacturers followed suit, replacing zinc white with lithopone in the making of white tablecloth, etc., and later on abandoning the use of white lead in floor cloth and linoleum. This gave an impetus to several chemical concerns, that erected plants and began to manufacture the pigment. Competition among the manufacturers and the activity of the importers induced other industries to experiment with lithopone, and the shade cloth makers, who formerly used white lead chiefly, are now among the largest consumers. Makers of India rubber goods, implement makers and paint manufacturers are also consumers of great quantities, and the demand is very much on the increase, as the nature of the pigment is becoming better understood and its defects brought under control. Large quantities find their way into floor paints, machinery paints, implement paints and enamel paints, while the flat wall paints that have of late come into such extensive use owe their existence to the use of lithopone in their makeup.
CSPI says it might reconsider its rating if specifications for food-grade titanium dioxide in the U.S. are updated to ensure nanoparticles are minimized, and new studies are conducted to assess its capacity to cause cancer or other health problems.
The assessment was conducted following a rigorous methodology and taking into consideration many thousands of studies that have become available since EFSA’s previous assessment in 2016, including new scientific evidence and data on nanoparticles.
The major applications studied in the report include paints & coatings, plastics, printing inks, paper & pulps, rubber, leather, linoleum, and others. Region-wise, the market is studied across North America, Europe, Asia-Pacific, and LAMEA. Presently, Asia-Pacific accounts for the largest share of the market, followed by North America and Europe.
Overall, the Food Directorate's comprehensive review of the available science of TiO2 as a food additive showed:
Restraint
This precipitate is not suitable for a pigment until it is filtered, dried, crushed, heated to a high temperature and quenched in cold water. The second heating in a muffle furnace at 725 °C produces crystals of the right optical size.