FDA Would Stretch a Packaging Exemption Into Food Ingredients

The FDA is proposing to let companies add some chemicals straight into food under a 1995 packaging exemption, without a full additive safety review. The change sits inside the August 11 proposed rule that would, for the first time, make companies file a notice when they call an ingredient generally recognized as safe.

That notice is the part Health and Human Services sold in August. The same document also rewrites 21 CFR 170.39, the threshold of regulation, so the old packaging tool could cover substances used in food, not only substances that migrate from a wrap or a machine.

The 1995 Rule Covered Only What Migrates From Packaging

Today’s TOR process is narrow on purpose. A company asks the FDA to treat a chemical in a food-contact article as too trivial to regulate as a food additive, and the agency runs an abbreviated file rather than a full additive petition.

Under the current text of 21 CFR 170.39, that path is for a substance in packaging or processing equipment that migrates, or may be expected to migrate, into food. The use has to stay at or below 0.5 parts per billion in the diet, which the rule pegs at 1.5 micrograms per person per day on a diet of 1,500 grams of solid food and 1,500 grams of liquid. The substance must not have been shown to cause cancer, and it must have no technical effect in or on the food it reaches.

That last condition is the tell. A flavor, a binder, an emulsifier or a processing aid is added because it does work in the food. A migrant from a bag liner is not supposed to. The proposal would open TOR to any substance used in food, added directly or indirectly, which is how a packaging file becomes an ingredient file.

Industry lawyers reading the draft say a granted TOR exemption would sit among the exceptions to the new GRAS notice duty, and that a TOR request would not need the full safety narrative a GRAS notice still requires. The FDA’s public TOR inventory listed 144 exemptions as of July 2026, all of them food-contact uses.

How 0.5 Parts per Billion Became the Line

The number is not a measured safe dose for each chemical. It is a 1995 policy line, drawn for things that were never meant to be in the recipe.

On July 17, 1995, the FDA issued the 1995 threshold of regulation rule after packaging and plastics groups asked for a cutoff on tiny migrants. The agency based 0.5 ppb on an analysis of the cancer potency of 477 chemicals. If an untested migrant later proved to cause cancer, the upper-bound lifetime risk at that dietary level was, in the agency’s words, likely to stay below one in a million.

The supporting claim still sits in that final rule. Carcinogenic effects in test animals, the FDA wrote, typically occur at lower dietary concentrations than noncancer toxic effects, so a line low enough for a hidden carcinogen would also cover ordinary toxicity. A second, separate gate still exists for chemicals already cleared as direct additives: extra contact use can qualify if dietary exposure stays at or below 1 percent of the acceptable daily intake.

CURRENT TOR VERSUS THE PROPOSAL

Restating 1.5 micrograms per person as a per-kilogram daily dose can lower the allowed mass for a small child compared with a flat adult plate. That is the agency’s defense of the rewrite. It does not change the original bet, which was that cancer is the effect you design the line around.

Hormone Chemicals Can Act Below a Cancer Threshold

Maricel Maffini, an independent food consultant who has worked on TOR files, put the collision in one sentence.

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, independent food consultant

Hormone-active chemicals are the hard case for that 1995 bet. Perchlorate, some phthalates, some bisphenols, some PFAS and some flame retardants are often discussed as noncancer hazards. They can still interfere with thyroid hormone, reproduction or brain development at doses far below a cancer bioassay’s comfort zone, and they do not need to be labelled carcinogens to fail a child.

CHEMICALS THAT CAN BITE BELOW 0.5 PPB

• Perchlorate: Blocks iodine in the thyroid; already cleared by TOR for some dry-food packaging.
• Some phthalates: Plasticizers tied to hormone and thyroid changes, mostly as migrants today.
• Some bisphenols: Hormone mimics used in resins and coatings that can move into food.
• Some PFAS: Persistent processing and packaging chemicals with thyroid and other hormone findings.
• Some flame retardants: Not classed as classic carcinogens in TOR terms, still bioactive at trace doses.

A single TOR file also does not add up the rest of the diet. One approved trace in a binder, another in a flavor, a third still migrating from a liner, and the 1995 line is being asked to judge a mix it never modelled. Maffini flagged flavorings in particular, because ultra-processed formulas use chemicals that work on mouth and nerve receptors to keep people eating.

Perchlorate Already Showed What the Old Rule Missed

The packaging version of TOR is not a thought experiment. In 2005 the German chemical firm BASF used it to clear perchlorate as an antistatic in giant polypropylene grain bags, the one-ton sacks that move rice, flour and oats. High-speed filling and emptying can strip the lining. Grains pick up the dust.

Perchlorate can iodide uptake into the thyroid, which cuts production of the hormone T4. Fetuses, infants and pregnant women are the groups the FDA itself lists as most at risk, because those hormones build the brain. The chemical may still be used, as of May 4, 2017, at up to 1.2 percent by weight of the finished polymer in certain containers and equipment that touch only certain dry foods.

FROM THE SACKS TO THE CEREAL BOWL

1. July 17, 1995: FDA finalizes TOR for food-contact migrants at 0.5 ppb.
2. 2005: A TOR exemption lets perchlorate serve as an antistatic in dry-food packaging, including grain super sacks.
3. 2008-2012: FDA’s Total Diet Study tests 5,464 food samples and reports no overall change versus 937 samples from 2005-2006.
4. May 4, 2017: After a petition and a fight over cereal data, FDA keeps a limited dry-food contact use and drops a gasket use.
5. March 2025: Health secretary Robert F. Kennedy Jr. directs FDA to end self-affirmed GRAS marketing without notice.
6. August 11, 2026: The GRAS-notice proposal publishes, with a rewrite of TOR in the same package.
7. December 9, 2026: Public comments on the whole document close.

The agency’s own perchlorate pages stress the all-food average. Across those 5,464 samples, FDA said it found no overall change and no consistent year-to-year shift, and it still publishes estimated average intakes for infants and toddlers of 0.36 to 0.48 micrograms per kilogram of body weight per day, under the EPA reference dose of 0.7. Advocates who pulled the children’s cereal rows out of the same tables say that average is the wrong lens, because dry baby cereal was where detects and high samples clustered after the 2005 exemption. Tom Neltner, now director of Unleaded Kids and formerly a scientist at the Environmental Defense Fund, has said the exemption file never took endocrine harm as the thing to measure.

That is the second-order lesson. A threshold built on cancer potency, then checked against a grocery-wide mean, can bless a use that lands on the first solid food a toddler eats. Direct addition would make that presence a specification, not an accident of a sack.

A TOR Grant Would Bypass the New GRAS Notice

On August 10, 2026, HHS announced mandatory notification for GRAS conclusions for substances added to human and animal food. Acting FDA commissioner Kyle Diamantas said the proposal was closing critical information gaps and giving the agency greater visibility into what enters the food supply. Kennedy had spent the 2024 campaign treating self-affirmed GRAS as the broken door, and in March 2025 he told the agency to shut it.

The draft would require a GRAS notice for a new self-made safety conclusion, with a time-limited streamlined path for uses already on the market, and it would post notices in a public inventory. Companies could still sell while a notice is pending. Failure to file would be a factor in later post-market review, not an automatic pull from shelves. Diamantas was careful to say this is not premarket approval. Congress would have to change the 1958 statute for that.

What the August materials did not lead with is section D of the same rule, the TOR rewrite. A substance that wins a TOR exemption would not have to take the new notice path. The press event was about seeing ingredients. The exemption is about not treating some of them as ingredients that need that file.

Maria Doa, a scientist at the Environmental Defense Fund, called the pairing by its result.

They’re widening another loophole, but trying to say they made our food safer. They did not make our food safer.

Maria Doa, scientist, Environmental Defense Fund

The GRAS problem the notice tries to map is already large. A 2026 review by Maffini and the Environmental Working Group of FDA and other federal food records found at least 111 food chemicals that companies had self-certified without telling the agency. Of those, 49 show up as labelled ingredients in thousands of products in the Agriculture Department’s Branded Foods Database. Between 2000 and 2024, companies sent FDA 863 voluntary GRAS notices; in the same span the agency reviewed 10 new food additives through the petition system and approved 7. In 2022, food made with tara flour, a self-GRAS ingredient that never got a voluntary notice, was tied to nearly 400 illnesses before FDA even had a file.

Mandatory notices would put names on that shadow inventory. They would not, by themselves, decide that a chemical is safe. TOR, if widened, would let some uses skip even that new postcard.

Shoppers Cannot See a TOR Ingredient

Nothing on a cereal box, a snack bar or a soda label has to say that a chemical rode in under 170.39. Current TOR chemicals are migrants, so they were never going to appear as ingredients. Direct TOR uses would be in the formula and could still be invisible if they are processing aids, enzymes or other substances that labelling rules do not treat as declared ingredients.

That is the consumer half of the category error. The 1995 rule assumed a trivial leftover from a package. The 2026 draft would let a company put a chemical in on purpose, stay under a cancer-era line, skip the GRAS notice the administration is advertising, and leave no phrase on the label a parent can search.

The docket is FDA-2025-N-3262. Comments on the whole package, TOR included, must arrive by December 9, 2026. Until a final rule issues, the packaging-only TOR still governs, perchlorate still has its limited dry-food contact use, and self-affirmed GRAS can still put a substance on a shelf without a notice. The fight in the file is whether a line drawn for dust from a sack should become a line for the recipe.

Disclaimer: This article is news reporting and analysis of a proposed FDA rule and related food-chemical science. It is informational only and is not medical, nutritional, legal or regulatory advice, and it is not a determination that any named food, brand or chemical will harm a given person. Readers who have questions about diet, thyroid disease, pregnancy or children’s feeding should consult a licensed physician, pediatrician or registered dietitian, and companies with compliance questions should consult qualified food-and-drug counsel. Figures, comment deadlines and the status of the proposal reflect the federal sources cited as of the dates on those documents and may change if the FDA revises or finalizes the rule.