The United States Food and Drug Administration (FDA) communicated to the Titanium Dioxide Manufacturers Association (TDMA) its position on the safety of titanium dioxide (TiO2) as a food additive.
The FDA confirmed that it considers TiO2 to be safe noting that “the available safety studies do not demonstrate safety concerns connected to the use of TiO2 as a colour additive.” The full response of the FDA is:
The FDA reviewed the findings of EFSA’s 2021 Opinion on titanium dioxide. The FDA notes that EFSA’s 2021 Opinion continued to confirm no general and organ toxicity, as well as no effects on reproductive and developmental toxicity. In its 2021 Opinion, EFSA noted that it could not rule out genotoxicity and included genotoxicity tests on titanium dioxide nanomaterials. Some of the genotoxicity tests included test materials not representative of the color additive, and some tests included administration routes not relevant to human dietary exposure. The available safety studies do not demonstrate safety concerns connected to the use of titanium dioxide as a color additive. The FDA continues to allow for the safe use of titanium dioxide as a color additive in foods generally according to the specifications and conditions, including that the quantity of titanium dioxide does not exceed 1% by weight of the food, found in FDA regulations at 21 CFR 73.575.
The TDMA welcomes the FDA’s position, which is consistent with the conclusions of other key global regulators including Health Canada, Food Standards Australia New Zealand (FSANZ), and the United Kingdom’s Food Standards Agency (FSA) and the growing scientific consensus over the safety of TiO2 as a food additive.
Additional background from the FDA:
The U.S. FDA regulates food and color additives under the Federal Food, Drug, and Cosmetic Act. Under this statute, food additives and color additives, including color additives such as titanium dioxide, require pre-market review and approval by the FDA. Federal regulations require evidence that each substance is safe at its intended level of use before it may be added to foods. In the case of color additives, manufacturers submit data and information to the FDA as a petition requesting approval of the intended use. The FDA evaluates the petition, and if the data available demonstrates that the substance is safe under the proposed conditions of use, the agency issues a regulation authorizing the use of the color additive. Post-approval, our scientists continue to review relevant new information to determine whether there are safety questions and whether the use of such substance is no longer safe under the Federal Food, Drug, and Cosmetic Act.
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