Advocacy Groups Seek to Ban Eight Substances Under Delaney Clause
A June 10, 2015, petition filed by consumer and environmental groups asks the Food and Drug Administration (FDA) to ban the following synthetic substances widely used in baked goods, ice cream and beverages: (i) benzophenone (also known as diphenylketone); (ii) ethyl acrylate; (iii) eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol); (iv) myrcene (also known as 7-methyl-3-methylene- 1,6-octadiene); (v) pulegone (also known as p-menth-4(8)-en-3-one); (vi) pyridine; (vii) styrene; and (viii) trans,trans-2,4-hexadienal. Signed by the Center for Science in the Public Interest, National Resources Defense Council, Center for Environmental Health, Environmental Working Group, Center for Food Safety, Consumers Union, and Improving Kids’. Environment, the petition claims that the flavorings are not safe for use in human food under the Delaney Clause of the Food Additives Amendment Act (21 U.S.C. § 348 (c)(3)(A)) because the National Toxicology Program and other agencies have linked them to animal or human cancers.
The groups argue that the Delaney Clause applies not only to food additives but also GRAS substances, urging FDA to establish “zero tolerance for seven flavors as well as one flavor, trans,trans-2,4-hexadienal, approved by the Flavor and Extract Manufacturers Association’s (FEMA’s) expert panel as ‘generally recognized as safe’ (GRAS).” They also remind the agency to remove acetamide and quinolone from its “Everything Added to Food in the United States” database as these two flavorings are no longer considered GRAS.
“Our view is consistent with FDA’s own regulations,” concludes the petition. “FDA regulations expressly state that the same safety standard applies to food additives and GRAS substances. Under the current regulations, GRAS status based on scientific procedures ‘require[s] the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient.’”
Issue 568
