What does Preamble of Ensuring Safe and Toxic-Free Foods Act of 2025 do?

This bill proposes amendments to the Federal Food, Drug, and Cosmetic Act. The proposed changes would impose requirements for substances generally recognized as safe. The bill would require the Commissioner of Food and Drugs to reassess the safety of chemicals added to food.

What does SHORT TITLE. of Ensuring Safe and Toxic-Free Foods Act of 2025 do?

This bill is formally titled the Ensuring Safe and Toxic-Free Foods Act of 2025.

What does SUBSTANCES GENERALLY RECOGNIZED AS SAFE. of Ensuring Safe and Toxic-Free Foods Act of 2025 do?

This section amends Chapter IV of the Federal Food, Drug, and Cosmetic Act by inserting a new section 409A regarding Substances Generally Recognized as Safe (GRAS). Under the new section, a substance intended for use in food is considered unsafe unless it complies with section 409 (food additives) or the manufacturer submits a notice to the Secretary and the Secretary does not object. Manufacturers can submit a notice to the Secretary concluding a substance is GRAS, including supporting information like investigation reports, hazard data, and evidence demonstrating the absence of carcinogenicity, reproductive toxicity, or developmental toxicity. The Secretary must make these notices publicly available and provide an opportunity for public comment. The Secretary can object to a determination if certain criteria are not met, including complete documentation and the absence of conflicts of interest among experts. The Secretary is authorized to reassess whether a substance is GRAS at any time. The Secretary is required to review at least 50 GRAS submissions annually. Section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act is amended to include substances not generally recognized as safe in compliance with section 409A as adulterants. Section 201(s) of the Federal Food, Drug, and Cosmetic Act is amended to include definitions related to GRAS substances. The amendments made by this section will take effect two years after the date of enactment.

What does FOOD CHEMICAL REASSESSMENT. of Ensuring Safe and Toxic-Free Foods Act of 2025 do?

This section amends the Federal Food, Drug, and Cosmetic Act by adding section 409B, titled 'Food Chemical Reassessment'. The Secretary is required to reassess the safety of at least 10 food substances or classes of substances every three years, starting within three years of the section's enactment. The reassessment will determine if the substance is safe and establish conditions of use, if any. The Secretary may require manufacturers of reassessed substances to provide data or conduct evaluations. The Secretary may prioritize reassessments based on food additive petitions, color additive petitions, or citizen petitions. In determining safety, the Secretary must consider information described in section 409A(a)(3)(B).

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Ensuring Safe and Toxic-Free Foods Act of 2025

Last updated: 7/17/2025 · Introduced: 7/17/2025

Author: Edward Markey (D-MA)

TL;DR (AI)

This bill establishes a new standard requiring food substances to be deemed safe either as food additives or through a process where the manufacturer submits documentation and receives no objection from the Food and Drug Administration (FDA).
The FDA is mandated to annually review at least 50 submissions determining whether substances are Generally Recognized as Safe (GRAS) and reassess existing GRAS substances.
The FDA must periodically reassess the safety of at least 10 food substances or classes of substances every three years, potentially requiring manufacturers to provide data or conduct evaluations.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 2 more.

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