FDA Proposed Food Additive Regulation Changes

The agency released a new proposal on August 11, 2026, to shift how it monitors ingredients added to food products.

Updated on Oct. 12, 2026 in Nutrition

FDA Proposed Food Additive Regulation Changes

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On August 11, 2026, the FDA proposed expanding its Threshold of Regulation system for substances intentionally added to food in the United States. This move includes shifting from a concentration-based limit to a daily intake limit based on body weight.

Why it matters

The FDA argues the new formula accounts for dietary consumption and physical differences, while also requiring manufacturers to submit formal notifications for Generally Recognized as Safe ingredients to increase transparency.

The proposed rule replaces the 0.5 parts per billion concentration benchmark established in 1995 with a limit of 0.025 micrograms per kilogram of body weight. The updated system explicitly excludes substances known or suspected to be carcinogens.

The players

Food and Drug Administration

This federal agency is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and the nation's food supply.

BASF

This multinational chemical corporation received a specific regulatory exemption for perchlorate in food packaging in 2005.

The details

The current GRAS system allows manufacturers to determine ingredient safety without FDA notification, a process the agency now seeks to standardize through mandated submissions. This proposal follows previous concerns, such as the 2005 BASF perchlorate exemption and 2017 data detecting perchlorate in children's cereals.

The Threshold of Regulation system was established in 1995.
BASF received a perchlorate exemption in 2005.
The FDA published perchlorate detection data in 2017.
The proposed rule was published in the Federal Register on August 11, 2026.
The public comment period for the proposal ends on December 9, 2026.

Health Landscape

The proposed change to the Generally Recognized as Safe notification system marks a significant regulatory departure from decades of industry self-regulation. By requiring formal submissions, the FDA is signaling an evolution in how it balances transparency with historical ingredient approval protocols.

These regulations aim to provide clearer oversight of substances added to food, potentially affecting the safety profiles of ingredients in consumer goods. Readers should note that the process for determining these safety thresholds will now incorporate individual body weight metrics for better precision.

The takeaway

The FDA proposal represents a shift toward more rigorous oversight of food additives by replacing older concentration limits with weight-based intake metrics. Consumers can track these changes through the federal regulatory process as the agency seeks to increase transparency in food safety.

What happens next

The FDA is currently accepting public comments on the proposed rule until December 9, 2026, after which the agency will review feedback before finalizing or amending the policy.