A direct final rule has been issued by the U.S. Food and Drug Administration (FDA) to complete administrative actions on the June 2015 determination that the use of partially hydrogenated oils (PHOs) in foods would no longer be considered Generally Recognized as Safe (GRAS). The release from the agency said that the 2015 final determination indicated that there were outdated references to partially hydrogenated oils in regulations that the FDA would address separately.
The agency established Jan. 1, 2021, as the final compliance date for manufacturers to remove the ingredients from products through reformulation. This move addresses artificial sources of trans fat in foods, but trans fat will not be completely removed from the food supply because of its natural occurrence in meat and dairy products as well as its low-level presence in other edible oils.
The direct final rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna, revises GRAS affirmation regulations to remove partially hydrogenated forms of menhaden and rapeseed oils, revokes the regulation for partially hydrogenated fish oil as an indirect food substance, and revokes the pre-1958 authorization of the use of PHOs in margarine, shortening, bread, rolls and buns.
The FDA anticipates no significant adverse comments on these amendments, and therefore is issuing them directly as a final rule. However, it is issuing a companion proposed rule in the same issue of the Federal Register in case the direct final rule is withdrawn due to receipt of such comments. The agency is looking to move forward with a proposed rule to put these changes in place. The direct final rule would be effective 135 days after the date of publication in the Federal Register.
