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IDFA Sends Comments on GRAS Status for Partially Hydrogenated Oil

Mar 12, 2014

Citing concerns about public health, the Food and Drug Administration last November released a tentative determination that aims to remove partially hydrogenated oils (PHOs) from the list of ingredients that are Generally Recognized as Safe (GRAS) in food. In comments filed last Friday, IDFA called on FDA to conduct a comprehensive review of the science, legal framework, regulatory policy and nutritional implications of revoking GRAS status before making a final determination.

The tentative determination was based on a study by the Institute of Medicine and the results of expert panels showing that trans fat found in PHOs contributes to heart disease. If the determination is finalized, companies that want to continue using partially hydrogenated oils in their products, either as ingredients or sub-ingredients, would need to petition FDA under food additive procedures.

Although most dairy products do not contain PHOs, some use the oil as an ingredient or sub-ingredient for a functional purpose, such as providing long-term stability. Examples include some ice cream inclusions and filled milk, which uses PHOs to provide stability for its 12-month shelf life.

Adequate Time and Flexibility

In the comments, IDFA stressed the importance of allowing adequate time for product reformulations and flexibility for smaller companies to meet the proposed change.

“Some suppliers to the dairy industry have estimated that the reformulation process for ingredients of dairy products, such as inclusions in ice cream, will take at least one year for the ingredients themselves,” the comments said. Regarding products that use PHOs to help with long-term stability, IDFA said, “Reformulated products will likely need to be held through their entire shelf life to test their performance.”

IDFA also called for the implementation date to align with other labeling changes, since product ingredient lists and some Nutrition Facts panels would be affected.

“This will allow all labeling changes to be made at one time to reduce the cost of development of new labels and reduce the waste of outdated labels,’ the comments said. “This cost savings will be especially important for small to medium sized companies that produce a large number of products, including many ice cream manufacturers.”

Read the comments here.

Read the Federal Register notice on "Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information.”

For more information, contact Michelle Matto, IDFA’s nutrition and labeling consultant, at

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