Environmental Concerns -Government Regulations

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Titanium Dioxide; Exemption from the Requirement of a Tolerance

(EPA Notice)

[Federal Register: March 25, 1998 (Volume 63, Number 57)]

[Rules and Regulations]

[Page 14360-14363]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr25mr98-18]

Toxicological Profile

Titanium is the eighth most abundant element in the earth's crust and consequently spontaneously enters the food chain to some degree. Titanium dioxide (TiO2) is a major constituent of a number of minerals, including rutile, which consists of 95% titanium dioxide. The most commercially important of the titanium compounds, titanium dioxide annual worldwide production is estimated to be approximately two million metric tons. Titanium dioxide is an opaque powder that is approved for use as a colorant in food (21 CFR 73.575), in drugs (21 CFR 73.1575), and in cosmetics (21 CFR 73.2575; 21 CFR 73.3126). It has an extensive range of industrial uses (e.g., paint, paper, and plastics). Titanium dioxide is currently exempt from the requirement for a tolerance when used as a colorant in pesticide formulations (40 CFR 180.1001(d)). A National Cancer Institute bioassay concluded that titanium dioxide did not affect mortality, and was not carcinogenic at dose levels of 25,000 or 50,000 ppm in rats or mice. The World Health Organization Committee on Food Coloring Materials has determined that no ADI need be set for the use of titanium dioxide based on the range of acute, sub-acute and chronic toxicity assays, all showing low mammalian toxicity, including a two year chronic feeding study in mice which was negative for carcinogenicity. Indeed, titanium dioxide is frequently used as a negative control material in vivo-chronic dust exposure studies and in in vivo assessments of fibrogenic potential of dusts.

Exposures and Risks

Titanium dioxide is currently approved for use in a significant number of pharmaceutical, cosmetic, industrial and food products. Therefore, the potential for aggregate exposure from dietary and non-dietary routes does exist for titanium dioxide. While it is difficult to develop a precise estimate of total human exposure to titanium dioxide, its low toxicity at relatively high doses indicate that current exposures are likely to be significantly below levels that may result in adverse health effects. Titanium dioxide is approved for use in food generally up to 1% of the final weight of the food (10,000 ppm). Even the most extreme assumptions regarding its presence in foods following use as an inert ingredient in lambda-cyhalothrin formulations would not result in a measurable increase in potential dietary intake of titanium dioxide.