How SmartSafety™ Helps Cosmetic Companies Meet MoCRA Compliance: Step by Step
- Connor
- Aug 27
- 2 min read
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MoCRA Requirement 1: Safety Substantiation
Companies must ensure and document that their products are safe under labeled or customary conditions of use.
How SmartSafety™ helps you do this:
Upload or build your product formulas directly in SmartSafety.
Link each ingredient to its toxicological profile and authoritative data sources.
SmartSafety automatically calculates Margin of Safety (MoS) and flags concerns based on regulatory thresholds.
Generate a safety assessment report from the system, structured to support MoCRA’s requirement for “adequate substantiation.”
Features used: Formulation editor, SmartSafety ToxDB integration, automated MoS calculation, report generator
MoCRA Requirement 2: Safety Documentation Must Be Available to FDA
Upon request, safety substantiation must be made available to the FDA.
How SmartSafety™ helps you do this:
All safety reports, formulations, and ingredient data are stored in one centralized, cloud-based repository.
You can retrieve full documentation instantly, including PDFs of reports, material safety data sheets, and referenced sources.
Your account has role-based access control, so authorized regulatory team members can access documentation securely.
Features used: Document management system, report archive, user roles, and permissions
MoCRA Requirement 3: Full Ingredient Disclosure
Must list all ingredients used in a product, including fragrance allergens above thresholds.
How SmartSafety™ helps you do this:
Raw material and formulation modules allow full traceability of every ingredient and sub-ingredient.
SmartSafety helps you track fragrance and allergen ingredients within your formulations, supporting your review and compliance efforts.
SmartSafety maintains INCI names, CAS numbers, functions, and concentrations for export to labeling or registration.
Features used: Material library, INCI/allergen tagging, threshold alerts
MoCRA Requirement 4: Facility & Product Registration
Requires listing of products and facilities with the FDA, including contact info and ingredients.
How SmartSafety™ helps you do this:
Export a MoCRA-ready product file with formula info, responsible person, facility address, and UFI.
Data is structured in line with what’s needed for the Cosmetics Direct FDA portal submission.
You can store and manage multiple product listings across brands or regions in one dashboard.
Features used: Product data exports, multi-product manager, registration record tracker
MoCRA Requirement 5: Serious Adverse Event Reporting
Companies must collect and report serious adverse events to the FDA within 15 days.
SmartSafety™ Today: While SmartSafety™ does not currently automate full adverse event reporting to the FDA, it could be enhanced in the future to support this workflow. Potential features could include:
Recording and tracking adverse event reports internally via a built-in incident log
Flagging incidents by severity and generating FDA-submission-ready forms
Tracking patterns across products to help improve safety over time
Features that could support this in the future: Adverse event module, reporting templates, dashboard alerts
MoCRA Requirement 6: Recordkeeping for 6 Years
Records must be kept for at least 6 years and be available for inspection.
How SmartSafety™ helps you do this:
All product records, safety assessments, and event reports are automatically timestamped and archived.
Data is stored securely in the cloud with version control and audit logs.
You can instantly search or export old records by product, ingredient, or date.
Features used: Document archive, search and retrieval tools, secure cloud infrastructure.
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