Health · Pharma & Biotech · 1 day ago
FDA proposal could expand food chemical exemption without safety review
The US Food and Drug Administration is proposing to expand an exemption that can let some chemicals enter food without a safety review.
The exemption currently covers certain chemicals that come from food packaging or processing equipment, at levels below 0.5 parts per billion and if they are not classified as carcinogenic.
The proposal would extend it to chemicals added directly to food, including as flavorings, preservatives and processing aids.
Health advocates say some chemicals can cause harm at levels below the current limit and that repeated exposure to different chemicals could add up.
They also warn that consumers would have no way to tell whether a product contains an exempted chemical.
The proposal was included in a rule presented as closing a separate route for ingredients to enter the food supply without standard review.
The FDA has not responded to a request for comment, and the proposal’s next steps are not stated.
The US Food and Drug Administration is proposing to expand its “threshold of regulation” exemption so some chemicals could be added directly to food without a safety review.
The existing exemption applies to certain food-contact materials and covers compounds that are not carcinogenic and are present below 0.5 parts per billion.
The proposed expansion could cover ingredients used as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders.
Public health advocates warn that some chemicals may cause harm at levels below the existing threshold and say the proposal does not account for cumulative exposure.
The FDA proposal says a substance can be exempted if there is “no appreciable risk to human health”; the agency did not respond to the Guardian’s request for comment.
- Who
- The US Food and Drug Administration; public health advocates and scientists oppose the proposed expansion.
- What
- A proposal to expand the threshold of regulation exemption for chemicals used in food.
- When
- Published 10 October 2026; the proposal’s date is not stated.
- Where
- United States
- Why
- The FDA proposal would exempt substances considered to pose no appreciable risk to human health; advocates warn the criteria could allow harmful chemicals into food without review.
US Food and Drug Administration
Public health advocates
The exemption standard
US Food and Drug Administration
The proposed rule says substances used directly or indirectly in food would be exempt from regulation as food additives if they pose “no appreciable risk to human health.”
Public health advocates
Advocates say the meaning of “appreciable risk” could allow chemicals that cause harm at very low levels to be used without a safety review.
Potential health effects
US Food and Drug Administration
The article does not provide a detailed FDA response to the advocates’ concerns; the agency did not respond to a request for comment.
Public health advocates
Advocates warn that the proposal could cover chemicals linked to effects such as brain damage, reproductive harm, immune-system impacts and harm to the microbiota, and say it does not account for cumulative exposure.
Food safety
US Food and Drug Administration
The proposal presents exemption as appropriate where there is no appreciable risk to human health.
Public health advocates
Advocates say the expansion could bring toxic chemicals into grocery-store foods without consumers being able to identify them.
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,
They’re widening another loophole, but trying to say they made our food safer,
They did not make our food safer.
BASF used the threshold of regulation exemption for perchlorate in “super sacks” used to move grains.
Robert F Kennedy Jr and the FDA declared “promises kept” over plans to close a different regulatory loophole known as “generally regarded as safe.”
The Guardian reported on the FDA proposal to expand the threshold of regulation exemption to chemicals added directly to food.
- Existing threshold
- Below 0.5 parts per billion
- Existing exemption scope
- Certain food-contact materials, including packaging and processing equipment
- Proposed direct food uses
- Flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders
- Chemical cited as an example
- Perchlorate, used in grain bags under an exemption obtained in 2005
- Article publication
- 10 October 2026
Sources
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