What Is Safety Substantiation?
Under the Modernization of Cosmetics Regulation Act (MoCRA), every cosmetic product sold in the U.S. must be adequately substantiated for safety. This means the Responsible Person must have information and data that reasonably supports the conclusion that the product is safe under its labeled conditions of use.
This is not new in concept — FDA has always expected safe cosmetics — but MoCRA makes it an explicit statutory requirement.
Who Is the Responsible Person?
Under MoCRA, the Responsible Person is the manufacturer, packer, or distributor whose name appears on the label. They are responsible for ensuring:
- Product safety substantiation exists
- The product is registered with FDA
- Adverse event reports are submitted when required
What Goes in a Safety Substantiation File?
A complete safety file typically includes:
1. Product Formula with Concentrations
Document each ingredient and its concentration (percentage). This is the foundation of any safety assessment.
2. INCI Ingredient Identification
Confirm each ingredient by its INCI name and CAS number.
3. Safety Assessment for Each Ingredient
Review available safety data for each ingredient, including:
- Cosmetic Ingredient Review (CIR) assessments
- SCCS (Scientific Committee on Consumer Safety) opinions (EU data is acceptable)
- Published peer-reviewed literature
- Supplier safety data sheets (SDS)
4. Product-Level Safety Assessment
Consider how ingredients interact in the finished formula:
- Stability data (temperature, light, shelf-life)
- Compatibility testing
- pH assessment (especially for leave-on products with low pH)
- Dermal penetration considerations for vulnerable populations
5. Toxicological Profile (Where Needed)
For novel ingredients or high-concentration formulas, a formal toxicological assessment by a qualified toxicologist may be needed.
6. Consumer Use Scenario
Document the intended use pattern: how much product, how often, leave-on vs. rinse-off, body area, consumer population (adult, child, professional).
7. Stability and Preservation Testing
Include:
- Accelerated stability testing results
- Challenge testing (preservative efficacy)
- Microbiological testing results
Children's Cosmetics: Higher Standard
MoCRA requires adequate substantiation to include special consideration for products intended for children under 11. If your product is marketed for children, FDA expects a higher level of safety scrutiny.
Common Gaps FDA Looks For
- No documentation — relying on "it's been fine for years"
- Ingredient safety data pulled only from supplier SDS (insufficient)
- No stability or preservation data
- Formula changes made without re-evaluating the safety file
- No consideration of vulnerable populations
How United Regulatory Can Help
We compile complete MoCRA-compliant safety substantiation files — ingredient screening, CIR/SCCS review compilation, consumer use scenario documentation, and coordination with toxicologists. Contact us to get your safety file in order.