FDA Files Petition to Remove Clearance for Styrene and Other Synthetic Flavoring Substances
The Food and Drug Administration (FDA) filed a food additive petition proposing that the food additive regulations be amended to no longer authorize the use of styrene and six other listed synthetic flavoring food additives, and to establish zero tolerances for the additives. The petition was submitted by the Center for Science in the Public Interest, the Natural Resources Defense Council, the Center for Food Safety, the Consumers Union, Improving Kids' Environment, the Center for Environmental Health, the Environmental Working Group, the Environmental Defense Fund, and James Huff.
Specifically, the petition proposes to amend Title 21 of the Code of Federal Regulations (C.F.R.) § 172.515, Synthetic flavoring substances and adjuvants, to no longer provide for the use of the following synthetic flavoring food additives and to establish zero tolerances for them:
- Benzophenone
- Ethyl acrylate
- Eugenyl methyl ether
- Myrcene
- Pulegone
- Pyridine
- Styrene
The petitioners contend that these substances are carcinogenic based on new data, including conclusions by the National Toxicology Program, the International Agency for Research on Cancer, and the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment. While the petition proposes to amend only § 172.515, FDA explained that its response to the petition could affect other regulations and clearances impacting these additives. For example, benzophenone is also approved for use as an indirect food additive, and ethyl acrylate, pyridine, and styrene are permitted for use by other food additive regulations and food contact notifications as reactants or manufacturing aids. However, the Agency noted that such uses are not the subject of these food additive regulations and food contact notifications, and as such, may not necessarily be affected if this petition results in a regulation.
FDA also pointed out that there is no statutory or regulatory provision for establishing a zero tolerance standard for flavoring food additives in § 172.515. However, Title 21 C.F.R. Part 189 permits FDA to prohibit the use of substances in human foods based on a determination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human foods.
Comments are due by March 4, 2016.