The U.S. Food and Drug Administration (FDA) has issued a direct final rule finalizing the agency’s prior determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS).
The direct final rule completes administrative actions that reflect the agency’s June 2015 final determination on the GRAS status of PHOs. In the 2015 final determination, FDA indicated that there were outdated references to PHOs in regulations that the agency would address separately. With respect to removing PHOs from the food supply, FDA established January 1, 2021, as the final compliance date to allow manufacturers time to reformulate foods and ensure an orderly transition in the marketplace.
FDA’s actions regarding PHOs address artificial sources of trans fats, but trans fats will not be completely removed from the food supply because of their natural occurrence in meat and dairy products and presence at very low levels in other edible oils.
The direct final rule:
- Revises regulations to no longer include PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna.
- Revises FDA GRAS affirmation regulations to no longer include partially hydrogenated forms of menhaden and rapeseed oils.
- Revokes the regulation for partially hydrogenated fish oil as an indirect food substance.
- Revokes pre-1958 authorization for using PHOs in margarine, shortening, bread, rolls, and buns. This authorization occurred before the enactment of the Food Additives Amendment of 1958 so such uses of PHOs could not be regulated as food additives.
FDA is issuing the present amendments directly as a final rule because the agency anticipates no significant adverse comments due to the original declaration of PHOs no longer being GRAS for any human food in 2015. However, the agency is issuing a companion proposed rule on the same issue in the Federal Register in case the direct final rule is withdrawn in the case of significant adverse comments, and because the agency needs to move forward with a proposed rule to enact changes.
FDA is accepting comments on both the direct final and proposed rules. Comments must be submitted no later than 75 days after publication in the Federal Register. Electronic comments can be submitted at regulations.gov. Written comments can be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20852
The direct final rule would be effective 135 days after the date of publication in the Federal Register.