Companies are recommended to identify suitable replacement ingredients and reformulate their food products two years after the rule is published in the Federal Register
The Food and Drug Administration (FDA) amended its food additive regulations to no longer allow the use of seven synthetic flavoring substances and flavor enhancers (adjuvants). The regulatory action came in response to two petitions, among which one petition pertained to six of the substances that reported to cause cancer at high doses in laboratory animals. The substances are synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine.
The Delaney Clause of the Federal Food, Drug, and Cosmetic Act requires that the F.D.A. cannot find as safe or cannot approve, the use of any food additive that has been found to induce cancer in humans or animals at any dose. “Although we are amending our food additive regulations for these synthetic flavoring substances in accordance with the Delaney Clause, the F.D.A.’s rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use,” said the FDA.
Furthermore, the FDA will not allow use of benzophenone, as a plasticizer in rubber articles intended for repeated use in contact with food. The petition was submitted by the Breast Cancer Fund, the Center for Environmental Health, the Center for Food Safety, the Center for Science in the Public Interest, the Consumers Union, the Environmental Defense Fund, the Environmental Working Group, Improving Kids’ Environment, the Natural Resources Defense Council, WE ACT for Environmental Justice and James Huff.
The FDA amended its food additive regulations to no longer allow for the use of styrene as a synthetic flavoring substance and adjuvant, after receiving a separate petition from the Styrene Information and Research Center. Electronic or written objections and requests for a hearing on the final rule must be sent to the FDA by 30 days after the rule’s publication in the Federal Register.