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An FDA proposal submitted for publication would expand the agency’s “threshold of regulation” exemption, potentially allowing some chemicals to be added directly to food without the usual food-additive review. The proposal’s scope and safety implications are disputed by public health advocates; the FDA did not respond to the Guardian’s request for comment.
The Food and Drug Administration is proposing to expand an exemption that could let companies add some chemicals directly to food without the standard food-additive safety review, according to a Guardian report published October 10. Public health advocates say the proposal could cover substances they consider harmful at low doses, while the rule’s safety test and its practical reach remain disputed.
The proposal would broaden the FDA’s threshold of regulation (TOR) exemption. The exemption currently applies to certain substances in food-contact materials, such as packaging and processing equipment, when they meet specified conditions. The Guardian reports that the proposed expansion could cover chemicals used directly in food as flavorings, preservatives, emulsifiers, enzymes, processing aids, stabilizers and binders, among other uses.
The proposed rule says a substance used directly or indirectly in food would be exempt from regulation as a food additive if there is “no appreciable risk to human health.” Advocates argue that the phrase is not adequately protective and that some chemicals may affect health at levels below the current TOR threshold of 0.5 parts per billion. The proposal text and the agency’s full scientific rationale were not supplied in the source material, so the precise criteria and substances that would qualify cannot be independently established here.
The Guardian reports that the FDA did not respond to its request for comment. The article also says the proposed TOR expansion was included in a proposed rule concerning the separate “generally regarded as safe” (GRAS) system, despite public messaging by Health and Human Services Secretary Robert F. Kennedy Jr. and the FDA in August that presented the agency as closing that loophole. Advocates have criticized the omission; the source does not establish that the agency concealed the provision deliberately.
Potential Reach Beyond Packaging
If adopted as described, the proposal could change how some ingredients and processing substances reach the food supply by extending an exemption beyond food-contact materials to chemicals put directly into food. That could affect a range of products and uses, though which substances would qualify and how often companies would rely on the exemption remain unclear.
Advocates’ concern is that a low concentration does not automatically mean a substance poses no risk. They also warn that people consume mixtures of chemicals across multiple foods, while the proposed standard, as described in the report, may not address cumulative exposure. The FDA’s reasoning and its treatment of these concerns will matter to consumers, manufacturers and public health researchers.
The proposal could also affect consumers’ ability to make informed choices. The Guardian reports that products containing TOR-exempted chemicals would not be identifiable to shoppers through a specific disclosure. Whether the rule would require any reporting or public listing is not clear from the material provided.
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The Perchlorate Precedent
The current TOR exemption has already drawn scrutiny over perchlorate, a chemical used in rocket fuel that can interfere with the thyroid’s uptake of iodine. According to the Guardian, BASF received a TOR exemption in 2005 for perchlorate in large polypropylene bags used to store and transport grains. Advocates say particles could transfer from the bags to grain as it was loaded and unloaded.
The article says FDA data published in 2017 showed an increase in the number of sampled children’s cereals containing perchlorate, as well as higher levels in individual samples. Six months after publishing the data, the FDA reapproved its use in the bags, the report says. The agency’s position, as recounted by the Guardian, was that it found no meaningful increase across the 250 foods measured. Critics argued that this broad comparison obscured the cereal findings. These competing accounts illustrate why the choice of data and health endpoints in any exemption review matters.
The new proposal is tied to the separate GRAS process, which has allowed some food ingredients to be marketed without formal FDA approval if they meet the applicable standard. The proposed TOR change would concern a different exemption; it should not be treated as proof that the FDA has already approved new direct-to-food uses.
““The FDA and industry have this position that if there’s only a little bit of something in the diet, then it’s not going to be problematic, but that isn’t supported by science of any kind.””
— Maricel Maffini, an independent food consultant who has worked on TOR issues, quoted by The Guardian
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Scope and Safety Test Unsettled
The available reporting does not establish which specific chemicals companies would seek to use under the expanded exemption, how the FDA would define “no appreciable risk,” or what evidence companies would have to submit. The proposal is not described here as a final rule, and the FDA’s response to the report’s questions was not available.
Advocates say the approach may fail to account for endocrine, neurological, immune or microbiome effects, and for exposure to multiple substances together. Those are advocates’ concerns; the source material does not provide a complete scientific assessment resolving them or the FDA’s responses. It is also unclear whether the proposal would permit substances formed as impurities to qualify even when the substance itself is carcinogenic, a secondary loophole raised in the report.
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Watch the Rulemaking Process
The next key development is publication and consideration of the proposed rule, including any opportunity for public comment and revisions before a final decision. The source material does not give a comment deadline or an expected date for agency action. The FDA’s eventual explanation of the risk threshold, evidence requirements and treatment of cumulative exposure will help show how broad the exemption could be.
Consumers and food-sector observers should distinguish the proposed expansion from a rule already in force: the report describes a proposal, not a final authorization of particular chemicals for particular foods. Any later agency decision, supporting analysis or response to public comments could clarify what uses are covered and what oversight remains.
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Key Questions
Has the FDA approved new chemicals for direct use in food?
No final approval is established by the source material. It describes a proposed rule that could expand an existing exemption; the proposal’s status and any later decision should be checked against current FDA records.
What is the threshold of regulation exemption?
The TOR exemption currently applies to certain substances in food-contact materials under specified conditions, including a low level of use. The proposed change would extend the exemption to some substances added directly to food, according to the report.
Which chemicals might be affected?
The report names perchlorate, some phthalates, bisphenols, PFAS and flame retardants as examples advocates say could raise concerns. It does not establish that these chemicals would qualify under the proposal or that any particular food use has been approved.
Why are advocates concerned about low exposure levels?
Advocates argue that some chemicals may cause harm at low doses and that exposure to multiple substances can add up. The FDA’s proposed standard is described as “no appreciable risk”; how the agency would apply that test remains unclear.
Can shoppers identify foods containing TOR-exempted chemicals?
The Guardian reports that consumers have no way to identify products containing a TOR-exempted chemical. The source material does not specify whether the proposed rule would introduce new labeling, reporting or public disclosure.
Source: hn
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