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US Cosmetics MoCRA Toxicological Risk Assessment (TRA)
MoCRA Toxicological Risk Assessment: A formulation review performed by a qualified safety assessor to evaluate cosmetic product safety and compliance with U.S. MoCRA regulations.
Price per sample:
$350
Additional information
| Turnaround Time | 2 weeks |
|---|---|
| documents_required | Ingredient list with % and CAS #'s |
| Sample Size | Ingredient List with % and CAS#'s |
US Cosmetics MoCRA Toxicological Risk Assessment (TRA)
MoCRA Toxicological Risk Assessment evaluates the safety of a cosmetic formulation in accordance with the U.S. Modernization of Cosmetics Regulation Act (MoCRA). This assessment reviews ingredient toxicology, exposure conditions, and product use to support regulatory compliance and responsible product placement in the U.S. market.
Under MoCRA, cosmetic manufacturers and brand owners must ensure that products are safe for their intended use. A toxicological risk assessment plays a central role in meeting this requirement. The review helps identify potential health risks associated with formulation ingredients and evaluates whether those risks remain acceptable under normal or reasonably foreseeable use conditions.
During a MoCRA Toxicological Risk Assessment, a qualified safety assessor reviews the full ingredient list, including concentrations, functional roles, and known impurities. The assessment considers toxicological data, exposure routes, frequency of use, and product type. This structured approach supports a science-based safety conclusion aligned with MoCRA expectations.
Manufacturers often request this assessment during product development, reformulation, or prior to market launch. In addition, companies use the review to support internal compliance programs, regulatory documentation, and safety substantiation files required under U.S. law.
The assessment does not involve animal testing. Instead, it relies on existing toxicological data, regulatory references, and human-relevant safety information. Because many regions restrict animal testing, this approach aligns with current regulatory and ethical standards.
A MoCRA Toxicological Risk Assessment also helps identify when additional testing may be appropriate, such as analytical verification, exposure refinement, or preservative efficacy studies. By addressing safety considerations early, manufacturers reduce regulatory risk and improve product readiness.
This service is commonly included within broader Regulatory Compliance Services and Product Safety Assessments. Guidance from the U.S. Food and Drug Administration (FDA) outlines MoCRA requirements and expectations for cosmetic product safety and documentation.
Overall, a MoCRA toxicological risk assessment provides a clear, defensible safety evaluation that supports compliance, protects consumers, and strengthens confidence in cosmetic products sold in the United States.
Description
US Cosmetics MoCRA Toxicological Risk Assessment (TRA)
MoCRA Toxicological Risk Assessment evaluates the safety of a cosmetic formulation in accordance with the U.S. Modernization of Cosmetics Regulation Act (MoCRA). This assessment reviews ingredient toxicology, exposure conditions, and product use to support regulatory compliance and responsible product placement in the U.S. market.
Under MoCRA, cosmetic manufacturers and brand owners must ensure that products are safe for their intended use. A toxicological risk assessment plays a central role in meeting this requirement. The review helps identify potential health risks associated with formulation ingredients and evaluates whether those risks remain acceptable under normal or reasonably foreseeable use conditions.
During a MoCRA Toxicological Risk Assessment, a qualified safety assessor reviews the full ingredient list, including concentrations, functional roles, and known impurities. The assessment considers toxicological data, exposure routes, frequency of use, and product type. This structured approach supports a science-based safety conclusion aligned with MoCRA expectations.
Manufacturers often request this assessment during product development, reformulation, or prior to market launch. In addition, companies use the review to support internal compliance programs, regulatory documentation, and safety substantiation files required under U.S. law.
The assessment does not involve animal testing. Instead, it relies on existing toxicological data, regulatory references, and human-relevant safety information. Because many regions restrict animal testing, this approach aligns with current regulatory and ethical standards.
A MoCRA Toxicological Risk Assessment also helps identify when additional testing may be appropriate, such as analytical verification, exposure refinement, or preservative efficacy studies. By addressing safety considerations early, manufacturers reduce regulatory risk and improve product readiness.
This service is commonly included within broader Regulatory Compliance Services and Product Safety Assessments. Guidance from the U.S. Food and Drug Administration (FDA) outlines MoCRA requirements and expectations for cosmetic product safety and documentation.
Overall, a MoCRA toxicological risk assessment provides a clear, defensible safety evaluation that supports compliance, protects consumers, and strengthens confidence in cosmetic products sold in the United States.
