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Cosmetic Toxicological Risk Assessment (TRA)

A qualified assessor evaluates your formula: reviewing the toxicological profile of each ingredient and calculating margins of safety against expected exposure, producing a report that supports the safety substantiation MoCRA requires.

BasisMoCRA safety substantiation
PrerequisiteComplete formula and conditions of use
TimelineA few weeks
DeliverableSigned TRA report
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What this service is

A Toxicological Risk Assessment (TRA) is a professional evaluation of a cosmetic formula's safety under intended conditions of use, typically covering a review of each ingredient's toxicological data, exposure estimation, and margin of safety (MoS) calculation, signed by a qualified assessor.

MoCRA requires the responsible person to maintain adequate substantiation of product safety. A TRA report is one of the core documents companies commonly use to build that safety substantiation file.

MoCRA (2022)FD&C Act §608

Who needs it

Brands and manufacturers that need a product safety substantiation file under MoCRA
Companies asked by marketplaces or customers for product safety assessment documentation
Products with novel or high-profile ingredients that need professional safety justification

Prerequisites and sequence

  • Provide the complete formula with exact concentrations and the product's conditions of use.
  • TRA is a desk-based assessment and does not replace laboratory testing; measured items such as microbiology or heavy metals are arranged separately.

Who holds regulatory responsibility

The legal duty of safety substantiation rests with the responsible person. We organize a qualified assessor to issue the report; you are responsible for consistency between the formula and actual production.

Materials we need from you

Complete formula (INCI names and exact concentrations)
Dosage form, application area, frequency of use, and target population
Raw material safety data (SDS, COA, etc.) where available
Existing test reports or historical safety data, where available

Process

  1. 01

    Collect and verify formula and product-use information

  2. 02

    Research and review toxicological data ingredient by ingredient

  3. 03

    Calculate margins of safety against expected exposure

  4. 04

    Identify ingredients of concern with conclusions or follow-up recommendations

  5. 05

    Issue the TRA report signed by the assessor

Deliverables

Signed TRA report
Ingredient toxicological review records
Guidance for organizing the safety substantiation file

Timeline

Once documents are complete, the assessment is typically finished within a few weeks, depending on formula complexity and the availability of toxicological data.

Scope

What we provide

  • Formula and exposure data organization
  • Ingredient toxicological review
  • Margin-of-safety calculation and conclusions
  • Signed assessment report

What is not included

  • Laboratory testing (microbiology, heavy metals, stability, etc.)
  • Animal or clinical testing
  • Safety assessments in other jurisdictions' formats, such as an EU CPSR (assessed separately)

What usually follows

Preservative Challenge TestMicrobial Limit TestHeavy Metals Test

Common pitfalls

Treating a TRA as a test reportA TRA is a professional assessment based on the formula and published data; microbiology and heavy metals are laboratory measurements on physical samples. The two complement each other — a TRA cannot stand in for lab testing.
Reusing the report after a formula changeAfter a change in formula or concentrations, the original conclusions may no longer apply. Arrange a reassessment or addendum, or the substantiation file will no longer match the actual product.
Assuming MoCRA prescribes a TRA as the only formatMoCRA requires adequate safety substantiation without prescribing a single document format. TRA is the widely adopted approach, but the file usually also needs supporting material such as lab test reports.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

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FAQ

Does MoCRA mandate a TRA?

MoCRA requires the responsible person to maintain adequate safety substantiation but does not prescribe a single document format. TRA is the widely adopted approach and is recognized by platforms and buyers.

Is a TRA the same as a test report?

No. A TRA is a professional assessment based on the formula and published data; microbiology and heavy metals are laboratory measurements on physical samples. The two complement each other.

Is the report still valid after a formula change?

After a change in formula or concentrations, the original conclusions may no longer apply and a reassessment or addendum is needed.

Related services

Cosmetic Ingredient ReviewA clause-by-clause check of your formula under the FDA framework: prohibited and restricted ingredients, color additive rules, and standardized nomenclature (INCI). Risk ingredients are flagged, laying the groundwork for label finalization and product listing.Preservative Challenge TestStandard organisms are inoculated into the sample and surviving counts are measured at set intervals to verify that the preservative system keeps microbial growth in check over the product's life. Commonly run to USP <51> or ISO 11930, with a report from a partner laboratory.Stability TestAccelerated and real-time conditions track changes in appearance, physicochemical, and microbiological indicators over the shelf life, providing the data basis for shelf-life setting, packaging selection, and safety substantiation.

Disclaimer

A TRA report is a professional opinion based on currently available scientific data. It is not a guarantee of absolute safety and not legal advice.