Five Facts about FDA Removing the ‘Generally Recognized as Safe’ Designation for Partially Hydrogenated Oil

On June 16, 2015, the U.S. Food and Drug Administration announced a final decision that partially hydrogenated oils would no longer be considered generally recognized as safe ingredients for human food applications, according to story from Food Business News. The final decision followed FDA releasing a preliminary determination about the generally recognized as safe status for partially hydrogenated oils in 2013. In the public comment period that stemmed from that preliminary determination, FDA collected more than 6,000 comments.

To comply with the new regulations, food companies must use partially hydrogenated oil alternatives by June 18, 2018. For entities that would like to continue using partially hydrogenated oil, they must pursue food additive approval, which requires submitting data that illustrates that the intended use wouldn’t cause harm within reasonable certainty, according to the Food Business News story.

The following points explain the circumstances that led to the FDA decision and the decision’s possible effect on the edible oils business, especially the soybean oil sector.

1. Partially hydrogenated oil has a history of functionality. The food industry has used partially hydrogenated oils since the 1950s, according to an FDA publication. For some oils, they naturally lack the stability and functionality that would be required for many applications. By partially hydrogenating oils, the oil products would have improved characteristics to promote shelf life and stability in processed foods.

2. Despite their functionality, partially hydrogenated oil contains artificial trans fat. In fact, partially hydrogenated oil is the chief artificial trans fat source in consumer diets. A 2002 study from the National Academy of Science’s Institute of Medicine linked trans fat to heart disease because the trans fat elevates LDL cholesterol levels, according to a publication from the Food and Drug Administration. If trans fat-related plaque accumulates within the arteries, then the blockage could trigger a heart attack.

3. To address the trans fat issue, FDA originally required trans fat labeling. Food products containing trans fat had to include a trans fat listing in the nutrition facts panel by 2006. If a product contained less than 0.5 grams of trans fat per serving, however, the food could still qualify for a “0 grams of trans fat” claim, according to the Food Business News story. In many cases, companies wanted to label their products with the “0 grams of trans fat” claim, so they reformulated their products to minimize or completely remove the trans fat, according to a publication from the Food and Drug Administration.

4. Removing the “generally recognized as safe” status for partially hydrogenated oil will further reduce trans fat exposure. The Food Business News story cites FDA data that suggests that U.S. trans fat consumption declined an estimated 78 percent between 2003 and 2012. However, some manufacturers – such as those that make crackers, cookies, cakes, snack foods, stick margarines, coffee creamers and ready-to-use frostings – may still include partially hydrogenated oil in their recipes, according to the Food and Drug Administration publication. Unless these manufacturers can successfully receive a food additive approval, they’ll need to reformulate to eliminate the partially hydrogenated oil.

5. For the soybean industry, removing partially hydrogenated oils may erode some soybean oil markets, but it has supported new technologies to compensate for the food industry phasing out partially hydrogenated oils. In a statement, the United Soybean Board suggests that the food industry still uses 2 billion pounds of partially hydrogenated soybean oil. When food companies are forced to change their oil sourcing, however, they’ll have two new soybean oil choices. They could choose interesterified soybean oil, which has undergone processing to have solid characteristics, or high-oleic soybean oil, which is a liquid oil with natural stability and doesn’t require partial hydrogenation.