Our General Counsel provided us with a memorandum put together on yesterday’s FDA pre-published direct final rule, “Revocation of Uses of Partially Hydrogenated Oils (PHOs) in Foods.” The Direct Final Rule completes the agency’s June 17, 2015, final determination that the use of PHOs in food is no longer GRAS. Specifically, the direct final rule:
- Revises the regulations to exclude PHOs as an optional ingredient in the standard of identity (SOI) for peanut butter (§ 164.150) and canned tuna (§ 161.190);
- Revises FDA GRAS affirmation regulations to no longer include partially hydrogenated menhaden (§ 184.1472) and low erucic acid rapeseed oil (also known as LEAR oil, canola oil, or rapeseed oil) (§ 184.1555) oils;
- Revokes the regulation for partially hydrogenated fish oil (§ 186.1551) as an indirect food substance; and,
- Revokes prior-sanctioned (pre-1958) authorization (i.e., prior to the Food Additives Amendment of 1958) for use of PHOs in margarine, shortening, and bread varieties (i.e., bread, rolls, buns).
Simultaneously, FDA issued a pre-published version a companion proposed rule, “Revocation of Uses of PHOs in Foods; Companion Document to Direct Final Rule” in case the Direct Final Rule is withdrawn due to the submission of significant adverse comments, and therefore, FDA would need to move forward with a proposed rule to enact changes.
Comments on the Direct Final Rule are due by October 23, 2023. Then, assuming it is finalized, the Direct Final Rule will be effective on December 22, 2023.
Email NIOP staff for a copy of the memorandum. Email leigh@niop.org
