Description
In theFederal Registerof August 9, 2023 (88 FR 53764), FDA (we) published a direct final rule entitled “Revocation of Uses of Partially Hydrogenated Oils in Foods” (“the final rule”). The final rule amends 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). We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the revisions made in the final rule and is intended to help small entities comply with the requirements established in 21 CFR parts 161, 164, 184, and 186.
Scope & Applicability
Product Classes
2Food product subject to standard of identity revisions
Food product subject to standard of identity revisions
Stakeholders
2Target audience for the compliance guide
Entities subject to the rule
Identified Hazards
Hazards
1Basis for revoking prior-sanctioned use of an ingredient
Related CFR Sections (5)
- 21CFR181.1§ 181.1 General.
(a) An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning of section 201(s)(4) of the Act is exempt from classification as a food additive. The Commissioner will publish in this part all known prior sanctions. Any interested person may submitRead full regulation →
- 21CFR184.1555§ 184.1555 Rapeseed oil.
(a) Fully hydrogenated rapeseed oil.Read full regulation →
- 21CFR184.1472§ 184.1472 Menhaden oil.
(a) Menhaden oil. [TABLE] Category of food | Maximum level of use in food (as served) Baked goods, baking mixes, § 170.3(n)(1) of this chapter | 5.0 percent Cereals, § 170.3(n)(4) of this chapter | 4.0 percent Cheese products, § 170.3(n)(5) of this chapter | 5.0 percent Chewing gum, § 170.3(n)(6) ofRead full regulation →
- 21CFR164.150§ 164.150 Peanut butter.
(a) Peanut butter is the food prepared by grinding one of the shelled and roasted peanut ingredients provided for by paragraph (b) of this section, to which may be added safe and suitable seasoning and stabilizing ingredients provided for by paragraph (c) of this section, but such seasoning and stabRead full regulation →
- 21CFR161.190§ 161.190 Canned tuna.
(a) Identity.Read full regulation →
See Also (8)
- Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing (Status: Final)
- Guidance for Industry: The Seafood List FDA’s Guide to Determine Acceptable Seafood Names (Status: Final)
- CPG Sec 500.200 Food Additives -"GRAS" (Status: Final)
- Guidance for Industry: Antimicrobial Food Additives (Status: Final)
- Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry (Status: Final)
- Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives (Status: Final)
- CPG Sec 562.550 Safety and Labeling of Waxed (Coated) Fruits and Vegetables (Status: Final)
- Guidance for Industry: Estimating Dietary Intake of Substances in Food (Status: Final)