The F.D.A. finalized its determination that phos, the primary dietary source of industrially produced trans fat, are not GRAS for use in human food.

ROCKVILLE, MD. — The U.S. Pharmacopeial Convention is proposing a new monograph that will define fully hydrogenated oils and fats and differentiate them from partially hydrogenated oils and fats. The USP also is proposing monographs for trans-resveratrol and paprika oleoresin, the USP said June 30. All three monographs will be included in the USP’s Food Chemicals Codex, 10th edition.

Partially hydrogenated oils (phos) contain fatty acids with trans double bonds and are linked to negative health effects, according to the USP.

“This monograph is particularly useful to manufacturers, regulators and other parties when formulating and reformulating their products because it is the first public standard to define exactly what fhos (fully hydrogenated oils) are and to provide a test and specification designed to differentiate them from phos,” said Kristie Laurvick, Ph.D., senior scientific liaison for food ingredients at the USP. “With the F.D.A.’s recently finalized determination that phos are not Generally Recognized As Safe (GRAS), it is important to provide manufacturers and food processors with tools to differentiate fhos from phos, allowing manufacturers to test their materials to rule out food fraud and to ensure the safety of their products.”

The Food and Drug Administration in the June 17 issue of the Federal Register finalized its determination that phos, the primary dietary source of industrially produced trans fat, are not GRAS for use in human food. The F.D.A. defined phos as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, with an iodine value (IV) greater than 4.

Trans-reveratrol is known for health benefits, including heart health benefits from resveratrol in red wine, according to the USP. The proposed trans-reveratrol monograph will be specifically for resveratrol produced by yeast fermentation.

“This represents the first proposed authoritative standard for resveratrol as a food ingredient,” said Jeffrey Moore, Ph.D., senior scientific liaison at the USP. “We are asking stakeholders to let us know how we should accommodate other potential sources of resveratrol in future FCC monographs.”

The proposed monograph for paprika oleoresin will provide methods of analysis designed to provide tools to detect and avert possible adulteration with undesirable, illegal and potentially carcinogenic dyes. Sudan dyes have been reported as one of such potential classes of adulterants in paprika oleoresin, according to the USP. Paprika samples containing Sudan dyes at levels consistent with economic adulteration, or 200 parts per million or above, would be expected to fail the tests included in the quality standard.

The USP is a global health organization that provides public standards and related programs to help ensure the quality, safety and benefits of medicines and foods. The USP will accept public comments on the three new proposed monographs until Sept. 31.