This article comes from “naturalnews.com”
- The FDA is proposing to expand a “threshold of regulation” (TOR) loophole that would permit toxic chemicals to be added directly to food as ingredients without safety review.
- The current TOR exemption applies only to food contact materials like packaging, but the expansion would allow dangerous compounds as flavorings, preservatives, emulsifiers and other direct food additives.
- Public health advocates warn the proposal ignores cumulative health effects and allows hormone-disrupting chemicals that cause harm at levels far below the 0.5 parts per billion threshold.
- The proposed rule comes as the FDA claims victory for “closing” the GRAS loophole, but critics say the TOR expansion would undermine any gains from that action.
- At least 111 food chemicals have already exploited the GRAS system to enter the food supply without FDA oversight, with 49 of those found in thousands of products
The regulatory shell game: How the FDA’s new loophole undermines food safety
The Food and Drug Administration is quietly proposing to expand a controversial regulatory loophole that would allow some of the world’s most toxic chemicals to be added directly to food without safety review, according to a report published Oct. 10. The “threshold of regulation” exemption currently permits dangerous compounds in food contact materials like packaging if they are not carcinogenic and present at levels below 0.5 parts per billion. But the new proposal would allow these chemicals as direct food ingredients—flavorings, preservatives, emulsifiers and processing aids—in ultra-processed products. The revelation comes as Robert F. Kennedy Jr. and the FDA declared victory for “closing” a different regulatory loophole called “generally regarded as safe,” yet the proposed rule submitted to the Federal Register includes the TOR expansion without public mention, prompting accusations of deception and raising fundamental questions about federal commitment to food safety.
The science of harm: Why low levels don’t mean safe
The fundamental flaw in the TOR expansion lies in its definition of “appreciable risk,” public health advocates argue. The proposed rule states any substance used in food will be exempted from regulation if there is “no appreciable risk to human health,” but the problem rests in how that risk is calculated. Chemicals like perchlorate, certain phthalates, bisphenols, PFAS “forever chemicals” and flame retardants are not classified as carcinogenic, yet they can cause harm at doses far lower than 0.5 parts per billion.
Independent food consultant Maricel Maffini, who worked on TOR issues, noted that many ingredients at very low levels cause serious issues in the body—particularly those that disrupt the endocrine system. The FDA’s own data from 2017 showed perchlorate levels increased in children’s cereal after the agency approved its use in grain bags through the TOR exemption. Perchlorate reduces the thyroid gland’s ability to produce hormones essential for proper brain development, with very low levels linked to lower IQ scores in children.
The rule also fails to account for cumulative effects from multiple chemical exposures, which scientists say could explain rising rates of chronic disease over recent decades.
The perchlorate warning: A story of regulatory failure
The case of perchlorate in children’s cereal serves as a stark warning about the TOR exemption’s dangers. In 2005, German chemical giant BASF used the loophole to exempt perchlorate from regulations for use in “super sacks”—one-ton polypropylene storage bags used on farms to transport grains. When grains are loaded into and emptied from these bags at high velocity, perchlorate and microplastics break off and contaminate the food.
FDA data published in 2017 showed the number of baby food dry cereal samples containing perchlorate increased from 5% to 15% after the 2005 TOR exemption. One sample of baby food dry rice cereal contained 173 parts per billion—far exceeding the maximum 11 ppb found before the exemption. Yet six months after publishing this data, the FDA reapproved perchlorate for use in super sacks, relying on flawed science that ignored the specific findings in children’s food.
The GRAS mirage: How secret determinations bypass oversight
The TOR expansion represents the latest chapter in a decades-long erosion of food safety oversight. The “generally recognized as safe” loophole, created in 1958 for basic ingredients like salt and vinegar, has been exploited by companies to self-certify new chemicals without FDA notification. After the 1997 rule change creating a voluntary notification system, nearly 99% of new food chemicals have come to market through the GRAS loophole, according to recent analysis.
The Environmental Working Group identified 111 food chemicals that exploited the GRAS standard, with 49 found in thousands of products. These include concentrated plant extracts like green tea catechins, which studies have linked to liver toxicity and other harms at high doses—information consumers have no way of knowing from product labels. The FDA has reviewed only 10 new food additives through its pre-market review system between 2000 and 2024, approving just seven.
A broken system, an uncertain future
The FDA’s proposed TOR expansion represents a major victory for the food industry at the expense of public health, advocates say. The rule—inconsistent with the agency’s stated mission of protecting consumers—relies on outdated science that ignores how low-dose chemical exposures accumulate over a lifetime. With more than 4,300 food ingredients on the GRAS list and no requirement for companies to notify the FDA, consumers remain in the dark about what is in their food and whether it is safe.
As federal inaction continues, states have begun stepping in. California banned four food chemicals prohibited in Europe. More than 30 states introduced food safety bills in 2025. But without meaningful federal reform to close the GRAS and TOR loopholes, require cumulative health assessments, and mandate transparent safety data, the American public remains exposed to potentially harmful chemicals with no way to know the true risks. The FDA’s proposed rule represents not progress but a dangerous step backward—one that prioritizes industry convenience over the health of the nation’s children.
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