US to Restrict the Use of Partially Hydrogenated Oils in Foods

On August 8, 2023, the U.S. Food and Drug Administration (FDA) issued an announcement titled Revocation of Uses of Partially Hydrogenated Oils in Foods, stating the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS). Besides, considering the public health risks associated with PHOs and the increasing popularity of PHO alternatives, FDA anticipates there will be no significant adverse comments from the industry and public. Therefore, if nothing else, this amendment will go into effect directly as a final rule on December 22, 2023.

According to FDA's announcement, while FDA's actions concerning PHOs target the artificial sources of trans fat, it should be noted that trans fat will not be entirely removed from the food supply due to its natural occurrence in meat and dairy products, as well as its presence at minimal levels in other edible oils.

The direct final rule includes：

• The use of PHOs as an optional ingredient in the identity standards of peanut butter and canned tuna has been revoked.

• FDA GRAS affirmation regulations concerning menhaden oil and rapeseed oil have been modified to prohibit the inclusion of PHOs.

• The regulation for partially hydrogenated fish oil as an indirect food substance has been revoked.  

• The provisions allowing the use of PHOs in margarine, shortening, and bread, rolls and buns have been repealed.

The FDA has estimated the costs associated with removing food products containing PHOs from the market. The cost covers the adjustment of product formulations, re-label products, search for alternative ingredients, and address changes in product functionality and sensory attributes such as taste, texture, and shelf life. In view of the great importance attached to food safety and health in the US, exporters should carefully consider the content of PHOs in their products to avoid customs detention due to non-compliance.

Recommended reading

GRAS stands for "Generally Recognized as Safe," which is an essential category in US food regulation. In simple terms, if a substance has been scientifically evaluated as safe for its intended use through rigorous scientific determination procedures by a panel of qualified experts with experience and expertise, then it is considered GRAS. Food manufacturers can use these GRAS approved ingredients in their new formulations without requiring FDA's approval.

On September 4, 2023, ChemLinked will host a free webinar introducing the different types of GRAS applications, as well as the administrative and technical requirements for GRAS notice. We invite you to register for the webinar by clicking here.