Catching a non-compliant ingredient after weeks of formulation work costs far more than catching it on day one. Uncountable has launched Regulatory Management, a new regulatory compliance software capability that checks every recipe ingredient against jurisdiction-specific limits at the point of formulation. Unlike conventional regulatory compliance software that operates in a separate system after formulation is complete, Uncountable's approach delivers a pass or fail result per market for each ingredient inside the same workflow formulators are already using.
Noel Hollingsworth, CEO and Co-Founder of Uncountable, explains the platform's core premise: "For decades the rulebook moved slowly enough that you could check compliance of the finished product and be fine. That assumption has stopped holding."
Why Late-Stage Regulatory Screening Is No Longer Workable
The limitation of conventional regulatory compliance software is that it sits outside the formulation environment and answers in batches. Ingredient regulation, meanwhile, has become faster-moving, more jurisdiction-specific, and more consequential for formulation decisions. An ingredient that passes in one market may fail in another at the same concentration, and permitted levels can vary by product category even for the same substance. The US and Canadian markets, for example, apply different permitted levels for common preservatives such as sodium benzoate, as illustrated in the Uncountable interface: the same 0.02% inclusion level receives a pass in Canada and a fail in the United States.
Uncountable's Regulatory Management checks every recipe ingredient against permitted levels for each target market, flagging non-compliant items at the point of formulation rather than in a downstream review.
Uncountable
The FDA's GRAS framework reflects the complexity underlying these determinations: even substances that are generally recognized as safe carry category-specific conditions of use, and those conditions are subject to regulatory review. A proposed FDA rule published in August 2026 would introduce additional oversight requirements for GRAS claims, signaling further regulatory tightening. For formulation teams, the practical implication is that a compliance check conducted on a finished specification can arrive too late to change which ingredients were explored.
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"We think compliance belongs alongside formulation rather than in a review that happens afterward," Hollingsworth notes, "and the software that people work with every day should reflect that."
Key features of Uncountable's Regulatory Management capability:
- Inline pass/fail status shown on the recipe page, per ingredient, per target market, updating as the formula is built
- Category-matched limits applied to the product category rather than to the ingredient in isolation
- Maintained regulations database kept current from official sources; teams do not update limits by hand
- Full citation per row showing jurisdiction, product category, permitted level, source URL, and date last checked
- Admin-controlled overrides allowing regulatory teams to record house interpretations of a rule, with required justification attached
- Change control via edit-lease that can be configured to lock recipe inputs and outputs, independent of pass/fail status
Where Regulatory Management Fits Formulation Workflows
The capability is built inside Uncountable's unified platform, which integrates electronic laboratory notebook (ELN), laboratory information management system (LIMS), product lifecycle management (PLM), and quality functions within a single structured data model.
| Conventional Screening | Uncountable Regulatory Management | |
|---|---|---|
| When Check Occurs | After formulation is complete | Inline, as ingredients are entered |
| Who Performs The Check | Regulatory affairs team, in a separate tool | Visible to the formulator in the recipe page |
| Market Coverage | Checked per request, sequentially | All target markets displayed simultaneously |
| Regulations Maintenance | Manual updates to shared spreadsheets | Official sources; database maintained by Uncountable |
| Citation Availability | Reconstructed on request | Attached to every row at the time of check |
For food and beverage teams, the practical scope is broadest. The regulations database currently has its strongest coverage in food ingredients, with jurisdiction coverage expanding. Cosmetics, specialty chemicals, and advanced materials teams are named as additional audiences, reflecting the multi-market regulatory exposure those sectors also navigate.
A failing result can be configured to block a recipe from being locked or published, keeping non-viable directions from advancing before anyone notices. This gating behavior is one feature that distinguishes embedded regulatory compliance software from a screening tool that reports findings after development is done. Brenda Jaroker, Product Manager at Uncountable, captures the design intent: "The database was never the hard part. Making the answer defensible was."
Raising The Standard For Formulation Compliance
Uncountable's Regulatory Management represents a category shift in how regulatory compliance software operates inside formulation teams: embedded at the point of recipe development rather than deployed as a post-development gate. For food and beverage formulators navigating a patchwork of jurisdiction-specific permitted levels, deploying regulatory compliance software inside the formulation workflow shifts the compliance check to the moment when it can still influence ingredient selection.
This article is based on a press release issued by Uncountable and was produced under Separation Science's AI Editorial Guidelines..
