Solution Briefs

Regulatory Management: check regulations while you formulate

Regulatory status usually lives in a separate system, owned by a separate team. Country limits get checked by hand against PDFs, and products get made in the lab that can't ship, then reformulated.

Uncountable Regulatory Management checks formulations against regulations while they are being formulated, at the point where the formula is still easy to change. A chemist adds a column for each jurisdiction and sees, ingredient by ingredient, how the formula measures up, without leaving the recipe. Each ingredient is matched by its CAS numbers and INCI names, including inside sub-recipes, and gets a status of Pass, Fail, Cannot Evaluate or No Match, with the regulation behind it: its citation, conditions, limit and units, the recipe amount and the margin to the limit.

Uncountable maintains the regulations from official sources, so your team does not have to build or maintain the library. This solution brief is for R&D formulators and regulatory teams who want to review and govern the rules in the same system the formulation data already lives in.

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Inside this solution brief:

  • How a check works, from the jurisdictions you pick to the status of each ingredient
  • How raw materials are matched to regulated substances, and what No Match means
  • Where the regulatory content comes from and how it stays current
  • Example sources by jurisdiction and sector
  • Overrides, approvals and the audit trail, and how refreshes keep your changes
  • Finding what a regulation change affects, and how checks connect to PLM and SDS

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Bring one formulation and one target market, and see the check run on your own recipe.

FAQs

How does a regulation check work?

Open a formulation and add a regulation column for one or many jurisdictions, or run an experiment check with a regulation scope. Each ingredient is matched by its CAS numbers and INCI names, including inside sub-recipes, and each ingredient that matches a regulation gets a status, shown on the formulation itself.

What status can an ingredient get?

Pass, Fail, Cannot Evaluate or No Match. Pass means the amount is within the limit, or the regulation permits the substance. Fail means the amount is outside the limit, the substance is prohibited, or the regulation requires a warning. Cannot Evaluate means a regulation matches but the check cannot reach a result. No Match means no regulation in the jurisdiction matched the ingredient, which does not mean compliant, so those ingredients should be reviewed.

Who maintains the regulations, and how current are they?

Uncountable does, from official sources such as government registers and published regulatory lists. Each rule is structured into substance, limit, units, basis and conditions, and every row cites the instrument it came from and links to its source. An Uncountable-managed agent re-extracts a source when its published text changes, rather than on a fixed release schedule.

Can we change a rule we interpret differently?

Yes. You can override a limit, exclude an ingredient, turn off a regulation, or correct the matching criteria of a substance. Overrides need approval, each records who created and approved it and when, and a content refresh saves your overrides and puts them back afterward.

How does Regulatory Management connect to PLM?

Check results show on the formulation and as columns in experiment listings, in the same platform as R&D, PLM and Quality. A check can be required for a valid product, and a formulation that passes all its checks can lock automatically.

See the Platform Behind the Guide

Uncountable connects R&D, quality, and product lifecycle data in one platform. Book a personalized demo and we'll show you how it applies to your lab.