FDA today announced that it has filed a petition submitted by the Grocery Manufacturers Association (GMA) to amend the food additive regulations to provide for the safe use of partially hydrogenated oils (PHOs) in limited food applications.
Readers may recall that FDA issued a declaratory order in June 2015 announcing its final determination that PHOs are not generally recognized as safe (GRAS). The FDA declaratory order, which has a compliance date of June 18, 2018, stated that PHOs are the primary dietary source of industrially-produced trans fatty acids and that there is no longer a consensus of expert opinion that artificial trans fats are safe in any human foods. The effect of the declaratory order is that, effective June 18, 2018, PHOs may not be used in any human food, unless such use is in accordance with a food additive regulation issued by FDA.
GMA has been developing a food additive petition that would allow the food industry to continue specific, low-level uses of PHOs. That petition reached its first milestone on October 1 when FDA accepted it for filing, marking the start of the agency’s formal review process. The Federal Register notice announcing the filing creates a docket, Docket No. FDA-2015-F-3663. FDA is now reviewing the potential environmental impact of the petition and is requesting public comments on GMA’s environmental assessment, which must be received no later than November 27, 2015. No doubt the docket will receive a large number of comments opposing the petition itself. Several consumer groups, including the Center for Science in the Public Interest, have already begun campaigns to oppose the GMA petition.
The GMA petition requests that FDA amend the food additive regulations to provide for the safe use of PHOs made from soy, cottonseed, coconut, canola, palm, palm kernel, and sunflower oils, or blends of those oils, at specified maximum use levels as a carrier for flavors or flavorings, as a diluent for color additives, as an incidental additive or processing aid (e.g., as a release agent), and as a direct additive in specified foods.
PHOs are defined by FDA as fats and oils that have been hydrogenated, but not to complete or near complete saturation, and that have an iodine value (IV) greater than 4. They are not the same as fully hydrogenated oils (FHOs) that have been hydrogenated to near complete saturation and that have an IV of 4 or less. According to FDA, FHOs generally contain small amounts of trans fat (i.e., less than 2 percent) and are not covered by the FDA declaratory order on PHOs.