FDA Proposes Letting Toxic Chemicals Into Food Without Safety Review

The US Food and Drug Administration is proposing to expand a controversial loophole that would allow some of the world's most toxic chemicals to be added directly to food without a safety review, according to a Guardian analysis published October 10, 2026.

The proposal has alarmed experts who track food safety policy. The FDA wants to widen the scope of an exemption that currently applies only to food contact materials — packaging and processing equipment — so it would cover chemicals added straight into the food supply.

What is the 'threshold of regulation' exemption?

The mechanism at the center of the proposal is the FDA's "threshold of regulation" (TOR) exemption. Under the rule as it stands today, the exemption applies to food contact materials. It permits dangerous compounds to be used without a review if two conditions are met:

• The compound is not carcinogenic.
• It is added at levels below 0.5 parts per billion (ppb).

That 0.5 ppb ceiling has defined the boundary of the loophole since its introduction for packaging and equipment. Chemicals falling under it bypass the safety review process that the FDA otherwise requires.

What would change under the proposal?

The FDA's plan would extend the same logic to chemicals added directly to food, according to the Guardian's reporting. Compounds that are not carcinogenic could enter the food supply without undergoing the agency's safety review, provided they stay under the regulatory threshold the agency sets.

The distinction matters. Food contact substances migrate into food only indirectly and typically in small quantities. Direct additives are deliberately introduced into products consumers eat. Applying the TOR exemption to the second category would remove the review step between a manufacturer's formulation decision and the consumer's plate for a class of chemicals the Guardian describes as "some of the world's most toxic."

Why are experts alarmed?

The Guardian reports that experts are alarmed by the direction of the proposal. Their concern centers on the scope of what the exemption could cover. The TOR framework asks a narrow question — is the compound carcinogenic, and is it below the threshold? — rather than a broader one about cumulative exposure, toxicity beyond cancer risk, or the effects of multiple compounds consumed together.

A chemical can fail to register as a carcinogen and still carry serious toxicological risks. By conditioning the loophole on non-carcinogenicity alone, the proposal would allow compounds that meet that single test to sidestep review entirely, experts warn.

The expansion would also mark a shift in burden. Under the current framework for direct food additives, the FDA's safety review stands between a new chemical and the market. Under the expanded exemption, review would simply not occur for qualifying compounds.

What's at stake for food companies and consumers?

For food manufacturers, an expanded TOR exemption would lower the compliance barrier for introducing new compounds, cutting out a review process that adds time and cost. For consumers, it would mean some chemicals entering the food supply without the FDA ever having assessed their safety in that context.

The Guardian's analysis, published October 10, 2026, frames the proposal as part of a broader pattern: the regulator "looks to expand loophole to allow dangerous compounds in food as long as they're not carcinogenic."

The FDA has not yet finalized the change. How the agency defines the threshold and which chemicals qualify under the expanded exemption will determine how much of the toxicology review apparatus — and the public's ability to see it applied — survives for direct food additives.