WASHINGTON, Jan. 4, 2016 -- The Food and Drug Administration will consider whether to ban the use of seven food additives based on their potential to cause cancer in humans or other animals.

In a Federal Register notice published Monday, Jan. 4, FDA said it will consider the request made in a petition submitted by the Natural Resources Defense Council and others.

“If we determine new data are available that establish these food additives induce cancer, then FDA will amend (its regulations) to no longer provide for their use,” the agency said in the Federal Register notice.

FDA approved the additives in 1964 but set no numerical limit on how much may be used in food, the petition said, adding that “the only limit” is Good Manufacturing Practices as defined in FDA regulations.

In 1965, the Flavor and Extracts Manufacturers Association (FEMA), which tests flavorings for the industry, added the substances to their “GRAS” (“generally recognized as safe”) list. FEMA also “describ(ed) average maximum use level in various foods considered by the trade association to be safe,” the petition said.

But federal law since 1958 has said that no additive “shall be deemed to be safe” if it is found to induce cancer in man or animal. In evaluations by organizations such as the National Toxicology Program (NTP) or the International Agency for Research on Cancer (IARC), as well as by the state of California, the substances have been classified as, at the least, possibly carcinogenic to humans.

NTP coordinates toxicology research and testing across the Department of Health and Human Services. IARC is part of the World Health Organization.

A table listing the additives, their uses, and the classifications they have received is included in the petition. They are: Benzophenone (also known as diphenyl ketone) (CAS No. 119-61-9); ethyl acrylate (CAS No. 140-88-5); eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol) (CAS No. 93- 15-2); myrcene (also known as 7-methyl-3-methylene-1,6-octadiene) (CAS No. 123-35-3); pulegone (also known as p-menth-4(8)-en-3-one) (CAS No. 89-82-7); pyridine (CAS No. 110-86-1); and styrene (CAS No. 100-42-5).

By law, FDA is supposed to make a decision on the petition within 60 days of publication in the Federal Register, but in practice, that rarely happens, said Tom Neltner, chemicals policy director at the Environmental Defense Fund, who helped prepare the petition.

FEMA recently removed styrene – one of the substances targeted in the petition – from its GRAS list.

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In a report issued earlier this year, FEMA said styrene should be taken off the GRAS list because “there is little evidence that (it is) used for the technical effect of flavoring.”

FEMA did not respond to a request for comment.

Besides NRDC, the other petitioners were Center for Science in the Public Interest, Center for Food Safety, Consumers Union, Improving Kids’ Environment, the Center for Environmental Health, the Environmental Working Group, and Dr. James Huff, the former associate director for chemical carcinogenesis at the National Institute of Environmental Health Sciences.

FDA says interested parties may submit comments on the petition through March 4.


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