MoCRA Cosmetic Safety Substantiation Bundle
From: $58.44
- Description
- Additional information
The MoCRA Cosmetic Safety Substantiation Bundle is a complete, lab-backed compliance package designed to meet the safety substantiation requirements of the U.S. Modernization of Cosmetics Regulation Act (MoCRA).
This bundle provides documented scientific evidence that your cosmetic product is safe under its intended conditions of use.
By combining toxicological documentation with essential laboratory testing, this bundle gives you a compliant safety file for the U.S. market.
What’s included in the bundle
MoCRA Cosmetic Safety Substantiation
A comprehensive safety substantiation confirming that your cosmetic product is safe for consumers when used as intended. This assessment is based on formulation data, ingredient safety information, and validated laboratory test results, in line with MoCRA requirements.
MoCRA Cosmetic Product Dossier
A structured cosmetic product dossier containing all required technical and safety documentation. This dossier supports FDA inspections, audits, and internal compliance checks, and serves as proof of due diligence under MoCRA.
Accelerated Stability & Compatibility Test
This test evaluates how your product behaves over time under accelerated conditions. It assesses:
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Physical and chemical stability
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Packaging compatibility
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Changes in appearance, odor, texture, and performance
The results help substantiate shelf life and product integrity.
Accelerated Stability Testing versus Thermal Shock Stability Testing
Both accelerated stability and compatibility testing and thermal shock stability and compatibility testing are used to evaluate how a product withstands environmental stress and simulates long-term aging under controlled, elevated conditions to predict shelf life. In both methods, compatibility between product and packaging is also evaluated to ensure no leakage, degradation, or interaction occurs.
| Feature | Accelerated Stability Testing | Thermal Shock Stability Testing |
|---|---|---|
| Purpose | Simulate long-term aging and stability | Simulate long-term aging and stability |
| Temperature Profile | Constant elevated temp (e.g. 4°C- 25°C–45 °C) | Alternating extremes (-15°C ± 2°C; +20°C ± 2°C; +45°C ± 2°C) |
| Duration | 95 to 105 days | 50 to 60 days |
| Simulation of | Time and aging | Time and aging, transport or rapid climate exposure |
| Typical Observations | Appearance, odor, color, pH, density, viscosity | Appearance, odor, color, pH, density, viscosity |
| Compatibility Test | Evaluates product–packaging interaction | Evaluates product–packaging interaction |
Microbiology Test
Microbiological testing verifies that your product meets accepted safety limits for microbial contamination. This is a critical requirement for consumer safety and regulatory compliance, especially for water-containing formulations.
Preservative Efficacy (Challenge) Test
A challenge test confirms that your preservative system is effective throughout the product’s lifecycle. It demonstrates that the formulation can control microbial growth during normal consumer use — a key pillar of cosmetic safety substantiation.
Certificate of Analysis (CoA) – Laboratory Test
An official Certificate of Analysis (CoA) issued by the laboratory, documenting the results of the performed tests. This certificate provides formal, traceable evidence to support your MoCRA safety file.
Additional information
MoCRA Cosmetic Safety Substantiation
| Your Product Recipe Ingredients | 1- 9 Ingredients, 10-29 ingredients, 30+ ingredients |
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Accelerated Stability and Compatibility Test
| Stability Test | Accelerated, Accelerated + Shelf Life Estimation, Thermal Shock, Thermal Shock + Shelf Life Estimation |
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Preservative Efficacy Challenge Test
| Challenge Test | EP/USP 51, ISO 11930, Mixed Culture, Preservative Synergistic Effect, Re-inoculation Protocol, Vegan |
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