The MoCRA Cosmetic Safety Substantiation Bundle is a comprehensive, laboratory-based 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 intended conditions of use.

By combining toxicological documentation with essential laboratory testing, this package provides you with a compliant safety dossier for the U.S. market.

What’s included in the package

MoCRA Cosmetic Safety Substantiation

A comprehensive safety assessment 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 accordance with MoCRA requirements.

MoCRA Cosmetic Product Dossier

A structured dossier of cosmetic products containing all required technical and safety documentation. This dossier supports FDA inspections, audits, and internal compliance checks and serves as evidence of due diligence under MoCRA.

Accelerated Stability and Compatibility Testing

This test evaluates how your product behaves over time under accelerated conditions. It assesses:

• Physical and chemical stability

• Packaging compatibility

• Changes in appearance, odor, texture, and performance

The results help substantiate shelf life and product integrity.

Accelerated stability testing versus thermal shock stability testing

Bothaccelerated stability and compatibility testing andthermal shock stability and compatibility tests are used to evaluate a product’s resistance to environmental stress and simulate long-term aging under controlled, elevated conditions to predict shelf life. Both methods also evaluate the compatibility between the product and the packaging to ensure that no leakage, degradation, or interaction occurs.

Microbiological testing

Microbiological testing verifies that your product meets accepted safety limits for microbial contamination. This is an essential requirement for consumer safety and regulatory compliance, especially for formulations containing water.

Preservative Efficacy (Challenge) Test

A challenge test confirms that your preservation 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 the cosmetic safety substantiation.

Certificate of Analysis (CoA) – Laboratory testing

An official Certificate of Analysis (CoA) issued by the laboratory, documenting the results of the tests performed. This certificate provides formal, traceable evidence to support your MoCRA safety dossier.