Headlines about food ingredients can make a complicated rule sound like a sudden change to what is on grocery shelves. A recent example is the FDA’s proposal to revise its “threshold of regulation” (TOR) pathway—a process that currently applies to some substances that migrate from food-contact materials into food.

The proposal would broaden that pathway to cover certain substances intentionally used in food as well as substances that reach food indirectly. That is significant, but it is still a proposal, not a new rule in force. It also does not mean that any ingredient below a single number is automatically approved or safe in every use. The details—exposure, intended use, available safety information, and FDA’s ability to decline an exemption—matter. [4]

What does “threshold of regulation” mean?

FDA’s existing TOR process is a narrow regulatory route for certain food-contact uses. A manufacturer can ask the agency to exempt a specific use when the amount expected to migrate into food is very low and the use meets other safety and environmental criteria. Packaging and food-processing equipment are examples of materials that can contact food. [1, 5]

Under the current regulation, the request is about a defined substance and use—not a general declaration that a chemical is harmless. The rule includes conditions related to carcinogenicity, dietary exposure, whether the substance has a technical effect in the food, and environmental impact. FDA also reserves the ability to refuse an exemption if available information indicates that the proposed use may pose a public-health risk. [1]

The pathway is sometimes described online as “no safety review.” That shorthand is misleading. The TOR request itself is a regulatory submission that requires information about the substance, its intended conditions of use, and expected dietary exposure. The evidence and decision are narrower than a full food-additive authorization, but there are still criteria and an FDA decision. FDA’s general consumer explanation also describes other authorization paths for food-contact substances, including food-contact notifications and food-additive regulations. [2, 5]

What would the 2026 proposal change?

FDA’s August 2026 proposed rule would revise the TOR regulation so that it could cover qualifying substances used in food directly or indirectly—not only substances migrating from a food-contact article. In the agency’s proposed framework, a qualifying use could be exempted from food-additive regulation or from the proposed GRAS-notification requirement. [4]

The proposal also replaces the current food-contact exposure benchmark of 0.5 parts per billion with an estimated daily intake benchmark of 0.025 micrograms per kilogram of body weight per day for one of the proposed eligibility routes. FDA says this body-weight-based measure is intended to account for differences in food consumption and body weight across subpopulations. A separate route is proposed for a substance already regulated for direct addition to food when the additional exposure from the proposed use is at or below 1% of its acceptable daily intake. [1, 4]

These are eligibility criteria in a proposed rule, not a general exposure limit for every food ingredient. The proposal also includes conditions about carcinogenicity and environmental impact, calls for information that lets FDA estimate exposure and review existing toxicological information, and retains FDA’s ability to decline a request if available information indicates a public-health risk. [4]

Does a low exposure number mean a chemical is “safe”?

Not by itself. A number only makes sense alongside the substance, the way it is used, the amount that could reach food, and the health and environmental information relevant to that use. The proposal is about a regulatory decision for an intended use that meets stated criteria; it is not a blanket safety rating for a chemical name wherever it appears.

It is also useful to distinguish a hazard from a risk. Hazard asks whether a substance can cause harm under some conditions. Risk assessment considers the likelihood and potential consequences under a particular exposure scenario. Very low estimated exposure can be relevant to a risk assessment, but it does not erase the need to identify the substance, consider impurities or other safety concerns, and define the use accurately.

That distinction is why packaging claims and ingredient databases need context. A chemical may have different uses, exposure routes, or regulatory statuses. A result for one packaging application cannot automatically be applied to another material, a different food, or direct addition as an ingredient.

How is this different from the GRAS proposal?

The same August FDA document also proposes a mandatory notification program for certain uses companies conclude are “generally recognized as safe” (GRAS). That is a separate part of the rule. The TOR revisions would provide another route for uses that meet the proposed threshold criteria; the GRAS provisions concern notifying FDA about certain GRAS conclusions. Both would change if finalized, and the proposal sets out exceptions and transition details. [3, 4]

If you have read our GRAS proposal explainer, keep the distinction in mind: “GRAS” and “threshold of regulation” are not interchangeable labels. They refer to different regulatory concepts, even though FDA’s proposal discusses how the pathways would interact.

What should shoppers do now?

For now, the practical step is to read claims about the proposal with the correct tense: FDA proposed changes; the existing regulation remains the current rule unless a final rule changes it. FDA is accepting comments on the proposal through December 9, 2026. [4]

This rulemaking does not identify a particular grocery item as unsafe, and it does not require shoppers to discard food or packaging. If you want to understand a product, start with its actual label and intended use. When evaluating packaging, a useful question is whether a claim concerns a specific material and contact condition or is making a broad claim about all products in a category. Our guide to PFAS in food packaging is one example of why a substance, use, and jurisdiction should be kept together when interpreting packaging rules.

Toxic Scan can help explain ingredient names on food and personal-care labels. It cannot determine how much of a substance migrates from a specific package, replace a regulator’s use-specific assessment, or predict an individual health outcome. Use it as a starting point, then check the product label and authoritative sources for the question you are trying to answer. You can learn more about the app on our ToxScan page.

The takeaway

FDA’s proposed TOR revision is an active food-ingredient policy story because it could broaden an existing low-exposure exemption pathway. But the proposal is not yet effective, and its criteria are not a universal “safe below this amount” rule. The most accurate way to follow it is to separate the current regulation from the proposed changes, pay attention to the specific intended use, and avoid turning a technical threshold into a verdict about every product.

References

  1. Electronic Code of Federal Regulations. (2026). 21 CFR § 170.39, Threshold of regulation for substances used in food-contact articles. Accessed October 14, 2026.
  2. U.S. Food and Drug Administration. (n.d.). Food Ingredients & Packaging. Accessed October 14, 2026.
  3. U.S. Food and Drug Administration. (n.d.). Generally Recognized as Safe (GRAS). Accessed October 14, 2026.
  4. U.S. Food and Drug Administration. (2026, August 11). Substances Generally Recognized as Safe; Proposed Rule. Federal Register, 91 FR 51834. Accessed October 14, 2026.
  5. U.S. Food and Drug Administration. (n.d.). Understanding How the FDA Regulates Substances that Come into Contact with Food. Accessed October 14, 2026.