mporter Program (VQIP) application portal for fiscal year 2025 would be opened on January 1, 2024. The VQIP, a component of the Food Safety Modernization Act (FSMA), is a voluntary fee-based program that allows for expedited review and importation of human and animal foods into the United States provided that importers meet certain requirements. Additional information is available at the link here.FDA Revokes Listings For Partially Hydrogenated Oils: On December 14, 2023, FDA confirmed an effective date of December 22, 2023, for a rule that revokes the generally recognized as safe (GRAS) status for partially hydrogenated oils (PHO) in food. 88 Fed. Reg. 86580. The direct final rule also revokes “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 FDA’s conclusion that these uses of PHOs may be injurious to health. Confirmation of the effective date follows FDA’s rule issued on August 9, 2023. 88 Fed. Reg. 53764.FDA Issues Updates To Instructions For Serious Adverse Event Reporting Requirement For Cosmetics: On December 14, 2023, FDA issued updates to the instructions for serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days.FDA defines the terms “responsible person, and “serious adverse event” at the link here. Serious adverse event reporting requirements, set forth in MoCRA, are enforceable by FDA as of December 29, 2023, but FDA does not intend to enforce these requirement

r 29, 2023, from 9:00 a.m. to 5:00 p.m. (EDT).FDA Issues Draft Guidance On Registration And Listing Of Cosmetic Product Facilities And Products: On August 8, 2023, FDA announced the availability of draft guidance to assist with facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). 88 Fed. Reg. 53490. FDA intends to make a new electronic portal available in October 2023, and is jointly developing a paper submission form. A facility registration number (FEI) will be required for each facility. FDA is accepting comments until September 7, 2023. Compliance is required by December 29, 2023.FDA Revokes Use Of Partially Hydrogenated Oils In Foods: On August 9, 2023, FDA published a direct final rule titled “Revocation of Uses of Partially Hydrogenated Oils in Foods,” which amends FDA’s regulations at 21 C.F.R. Parts 161, 164, 184, and 186 to no longer permit use of partially hydrogenated oils (PHO) in various applications. 88 Fed. Reg. 53764. The revocation follows FDA’s determination in June 2015 that PHOs are no longer considered GRAS. 80 Fed. Reg. 34650. The rule revises FDA’s regulations regarding GRAS substances that contain PHOs and revokes prior sanctioned uses of PHOs. FDA states that “[w]e 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.” The rule is effective December 22, 2023. FDA is accepting comments until October 23, 2023.NANOTECHNOLOGYEC Committee Updates Guidance On The Safety Assessment Of Nanomaterials In Cosmetics: On June 26, 2023, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the second revision of its Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The Guidance covers the main elements