The U.S. Food and Drug Administration (FDA) is amending its food additive regulations in response to two food additive petitions, to no longer allow for the use of a total of seven synthetic flavoring substances. The FDA determined that the data presented in one of the petitions submitted to the FDA by environmental and consumer groups, including the Natural Resources Defense Council, the Center for Food Safety, and the Center for Science in the Public Interest, show that six of these synthetic substances caused cancer in laboratory animals under the conditions of the studies. The seventh synthetic flavor is being delisted because it is no longer used by industry.

The six flavoring substances include synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine. These substances are being removed from the food additive regulations under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This clause, enacted in 1958, requires that the FDA cannot find as safe the use of any food additive that has been found to induce cancer in humans or animals at any dose.

Although the agency is amending its food additive regulations for these synthetic flavoring substances in accordance with the Delaney Clause, the FDA’s scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use. The synthetic flavoring substances that are the subject of this petition are typically used in foods available in the U.S. marketplace in very small amounts and their use results in very low levels of exposures and low risk.

While the FDA’s recent exposure assessment of these substances does not indicate that they pose a risk to public health under the conditions of their intended use, the petitioners provided evidence that these substances caused cancer in animals who were exposed to much higher doses. As such, the FDA is only revoking the listing of these six synthetic flavorings as a matter of law. The FDA has concluded that these substances are otherwise safe.

In response to a separate food additive petition from the Styrene Information and Research Center, the FDA is granting the petition by amending its food additive regulations to no longer allow for the use of styrene as a synthetic flavoring substance because the industry has abandoned this use.

For the other six synthetic flavoring substances, the FDA will provide until October 9, 2020 for companies to identify suitable replacement ingredients and reformulate their food products.

Federal Register notice

FEMA press release

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