The Food and Drug Administration had amended its food additive regulations to no longer allow for the use of seven synthetic flavoring substances and flavor enhancers (adjuvants), the agency said Oct. 5. The regulatory action came in response to two petitions. More details may be found here.
Companies will need to have identified suitable replacement ingredients and have reformulated their food products two years after the rule is published in the Federal Register.
One petition pertained to six of the substances that were shown 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 F.D.A. said 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,” the F.D.A. said. “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.”
The F.D.A. also no longer will allow the 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.
After receiving a separate petition from the Styrene Information and Research Center, the F.D.A. amended its food additive regulations to no longer allow for the use of styrene as a synthetic flavoring substance and adjuvant because the industry no longer uses it.
Electronic or written objections and requests for a hearing on the final rule must be sent to the F.D.A. by 30 days after the rule’s publication in the Federal Register, which was scheduled for Oct. 9. Electronic comments may be sent through the www.regulations.gov web site. Written comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852.