Regulatory Management

A limit changes. You know which formulas fail the same day

Uncountable maintains its own regulations database from official sources, checked inline on every recipe. When a source updates a limit, every recipe already checked against it reflects the new rule: so the question "what does this change cost us" has an answer before the meeting, not after a screening project.

Your analyst stops maintaining limits
Regulations are ingested and refreshed from official sources. Nobody on your team updates a row by hand
The fail arrives while it's cheap
Pass or fail per market, inline on the recipe, as ingredients and levels go in
The basis is already attached
Jurisdiction, category, limit, source and last-checked date travel with the recipe, so a customer or auditor request is answered rather than reconstructed

Used by the world's leading companies

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Beiersdorf
Clariant
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Total Energies Logo
St Jude Logo
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Dow company logo with white text on a red diamond-shaped background
Syngenta company logo with a green leaf above the letter g.
Beiersdorf
Clariant
Mondelez International logo with the tagline Snacking Made Right in purple text.
Total Energies Logo
St Jude Logo
Lubrizol company wordmark logo with blue curved line underneath the text.
Regulatory Management

What is regulatory management for formulation teams?

Regulatory management software helps product-development teams understand whether a formulation meets the requirements of the markets where it will be sold.

For formulation teams, that means more than storing regulations in a separate database. These need to be checked against the actual recipe as it is developed:

Limits
Categories
Jurisdictions
Sources
Interpretation rules

Uncountable brings regulatory screening into the formulation workflow. Teams can see pass or fail by market while ingredients and levels are being evaluated, with the source, jurisdiction, limit, and last-checked date retained alongside the recipe.

Market screening results for F-1182 v4 Preservative PX-2 at 1.2%, showing passes in 3 of 4 markets: European Union failed with a 1.0% limit, United States passed with a 1.5% limit, Canada passed with a 2.0% limit, and Japan passed with no restrictions.

Check as you formulate, not after

Uncountable checks regulatory status right on the recipe page, in the same system the formulator is already working in. As ingredients and levels go in, the pass or fail for every market updates immediately, so a direction can be adjusted while it's still cheap to change, not after weeks of work are already behind it.
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Recipe for Apple Juice from Concentrate showing ingredient list with quantities and regulation status in US and Canada. Sodium Benzoate at 0.02% fails US regulations but passes in Canada, flagged with a warning. Other ingredients include Apple Juice Concentrate 16.4%, Ascorbic Acid 0.045%, Citric Acid 0.1%, Dimethyl Dicarbonate 0.025%, Filtered Water 83.32%, Malic Acid 0.05%, Potassium Sorbate 0.03% passes both countries, Sulphur Dioxide 0.01% passes Canada. Total step quantity is 100 grams. A note indicates Sodium Benzoate exceeds the US limit and was flagged when entered.

Compliance checked in the recipe


Fully customizable, when your team's interpretation of a regulation differs from Uncountable's default reading, an admin can override it for that jurisdiction and ingredient, with a required justification attached. The override is gated to admin permissions and stays on the record, so the platform reflects your house rules without losing track of what was changed or why.

1
Select markets
Every market you sell into
2
Build the recipe
Ingredients as you formulate
3
Map to rules
Matched to the product category
4
Pass / fail shown
Inline, one column per market
5
Change control
Edit-lease keeps changes accountable
6
Recipe cleared
Basis set as formulated or finished

Status sits on the recipe being built, not in a separate tool alongside it.

1
Pass or fail, shown inline

Formulators see the status for every market on the recipes page as they build, a green Pass or red Fail computed live against the regulation's limit.

2
Every market checked at once

One column per market, so a fail in one market is visible immediately, not discovered later in a separate review.

3
The basis is yours to set

Check the recipe as formulated or the finished product, whichever your team uses, via per-family basis calculations.

Table showing composition of apple juice from concentrate with ingredients listed as Apple Juice Concentrate, Citric Acid, Malic Acid, Potassium Sorbate, Sodium Benzoate, and Sulphur Dioxide. The US column has no values or regulations, while the Canada column marks Sodium Benzoate with a green 'Pass' label. The step total is 100 grams. A note below states no US regulations matched for this formulation.

Uncountable maintains its own regulations database from official sources, and every row carries its citation.

4
Jurisdiction, category, limit, source

Every row carries jurisdiction, product category, the permitted level with units, a pinned source URL, and the date it was last checked.

5
Kept current, not maintained by hand

Regulations are ingested and refreshed from official sources across covered jurisdictions, so your team never updates limits manually.

6
A source update finds every recipe automatically

When an official source updates a limit, every recipe already checked against it reflects the change, without someone tracking it down.

Regulatory details for Sodium Benzoate in apple juice from concentrate in Canada, showing jurisdiction as Canada, CAS Number 532-32-1, use function as standard of identity, and maximum allowed concentration of 1000 parts per million, sourced from Canadian Standards of Identity, Volume 4, with a related file for Grape Juice from Concentrate having the same 1000 ppm limit.

Recipe edits can be locked down independently of the regulatory check itself.

7
An edit-lease locks the recipe

A workspace-level change-control setting can require an edit-lease on a recipe's inputs and outputs before changes are made.

8
Independent of the pass/fail status

The edit-lease is a records-integrity control, configurable per workspace. It doesn't key off the regulatory status; it governs who can change a recipe and when.

9
Time-boxed, so nothing stays locked by accident

A lease expires on its own; there's no manual step to release it, and no lock left open after someone forgets.

User interface for requesting a recipe lease in a change control system showing reason 'Modifications during Experiment Run', lease scopes 'Input' and 'Output', and a note about adjusting homogenization pressure setpoint after re-verification of pasteurization hold. A green label indicates the lease is recorded, with a message about 59 minutes remaining on this time-boxed and self-expiring lease.

Six moments this changes

source update

A regulation changes. When an official source updates a limit, every recipe checked against it reflects the new rule, without someone tracking it by hand.

Portfolio

Auditing the active portfolio. Checking every active recipe against its markets at once, rather than recipe by recipe on request.

customer rfi

A customer or auditor asks for the basis. The governing regulation, the source and the last-checked date are already attached to the recipe, not reconstructed after the request.

new market

Entering a market you haven't checked before. Select the market and every existing recipe checks against it, rather than starting a manual screening project from zero.

substitution

Swapping an ingredient. A substitution that changes the compliance picture shows up on the recipe immediately, not after the reformulation is finished.

Reformulation

A formula update changes the outcome. A recipe that passed can fail after a reformulation, and the change is visible on the recipe itself.

What changes for regulatory, R&D, and product teams

Regulatory management becomes more useful when it is connected to the product record rather than treated as a final review step.

Formulators

See the compliance impact of an ingredient, level, or substitution while the cost of changing direction is still low.

Regulatory teams

Spend less time maintaining limits manually and more time reviewing exceptions, interpreting requirements, and managing higher-risk decisions.

R&D leaders

Understand whether a proposed formulation direction is viable across intended markets before more development work is committed.

Quality and product teams

Retrieve the regulatory basis attached to the recipe when a customer, auditor, or internal stakeholder asks for evidence.

Portfolio teams

Assess the impact of a regulatory change across affected formulas, rather than manually reconstructing the exposure recipe by recipe.

The regulation is visible as you formulate, not after.

Your own regulations database, kept current from official sources, checked inline on every recipe.

FAQs

Does a failing result stop a recipe from being released?

Not directly today. The Pass/Fail status is computed live and shown inline, but it doesn't itself gate a lock or publish action. A separate, workspace-level change-control setting can require an edit-lease on a recipe's inputs and outputs; that's a records-integrity control, not a regulatory pass/fail gate. Confirm current behavior with your account team if a hard release gate matters to your evaluation.

Which markets are covered?

Coverage is bounded by what's been ingested into the regulations database, currently strongest in food, with jurisdiction coverage expanding. "Every market you sell into" depends on your product category and markets; confirm current coverage with your account team.

Can a recipe be locked down from further edits?

Yes, separately from the pass/fail status. A workspace-level change-control setting can require an edit-lease on a recipe's inputs and outputs, so edits are controlled and attributable. It's a records-integrity control, not a regulatory gate.

What is regulatory screening software?

Regulatory screening software checks a product, recipe, ingredient, or formulation against applicable regulatory requirements. For formulation teams, it helps identify whether ingredient levels, product categories, and target markets create a pass or fail outcome before the formulation is finalized.

How does regulatory management help formulation teams?

Regulatory management helps formulation teams see the compliance impact of ingredients and levels while they are developing a recipe. Instead of completing a formula and sending it for a separate review, teams can check relevant markets inline, adjust direction earlier, and retain the regulatory basis with the recipe.

How can companies manage regulatory changes across an existing product portfolio?

Companies can manage regulatory changes more effectively when regulatory sources, limits, jurisdictions, and product records are connected. When an applicable rule changes, teams can identify the recipes already checked against that rule and assess the potential impact across the portfolio.

Can regulatory management software support ingredient substitutions?

Yes. When an ingredient or level changes in a recipe, formulation teams can evaluate how that substitution affects regulatory status across the relevant markets. This helps teams identify issues while reformulation is still in progress rather than after the work is complete.

Find out what a limit change would cost you.

Bring one formula and the markets you sell into. We'll check it live against the regulations database, citations attached: your product, not a slide deck.