HS Code(s): 15; ICS Code(s): 67. Partiallyhydrogenated oils for use in human food

Revocation of Uses of Partially Hydrogenated Oils in Foods; Direct Final Rule

The Food and Drug Administration (FDA or we) is amending our regulations that provide for the use of partially hydrogenated oils (PHOs) in food in light of our determination that PHOs are no longer generally recognized as safe (GRAS). The rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna. It revises FDA's regulations affirming food substances as GRAS pertaining to menhaden oil and rapeseed oil to no longer include partially hydrogenated forms of these oils, and deletes the regulation affirming hydrogenated fish oil as GRAS as an indirect food substance. We are also revoking prior sanctions ( i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health. We are issuing these amendments directly as a final rule because they are noncontroversial given the public health risks associated with PHOs and the increasing use of PHO alternatives, and we anticipate no significant adverse comments because PHOs were declared no longer GRAS for any use in human food in 2015.

This rule is effective 22 December 2023. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by 23 October 2023. If FDA receives no significant adverse comments within the specified comment period, we intend to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, FDA will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends and we will then proceed to respond to comments under the companion proposed rule using the usual notice and comment procedures.