Under the Modernization of Cosmetics Regulation Act (MoCRA), every cosmetic product marketed in the United States must have adequate safety substantiation — meaning the manufacturer or Responsible Person must maintain records and evidence demonstrating that the product is safe for its intended use.

The law defines adequate substantiation as tests, studies, research, analyses, or other evidence considered by qualified experts to provide a reasonable certainty of safety under normal or reasonably foreseeable conditions of use.

If a product lacks adequate safety substantiation, it may be considered adulterated under MoCRA.

What Must Be Covered in a Safety Substantiation

To satisfy MoCRA, your safety substantiation dossier should include:

Ingredient-Level Safety Data
For each ingredient in your formula, you need chemical, toxicological, and exposure-based data. Existing safety assessments and peer-reviewed literature can be used where applicable.

Dose/Exposure and Risk Assessment
Your substantiation must consider how much of the product a typical user applies, how frequently, the level of skin absorption, and potential cumulative exposure or interactions. The evidence must demonstrate that the product is safe under expected use conditions.

Product-Level Testing or Supporting Evidence
This may include:

• Stability testing to confirm the formulation remains safe during shelf life

• Preservative efficacy or microbial challenge testing

• Irritation and sensitization assays such as patch or repeat insult patch tests

• In vitro or in silico testing methods as suitable non-animal alternatives

Documentation and Rationale
Each decision — such as test selection, safety thresholds, and risk margins — should be clearly justified and supported with traceable data, protocols, and analyses.

Organized Record-Keeping
All primary data, summaries, protocols, and supporting materials must be properly catalogued and accessible for FDA inspection.

Regulatory Context and Requirements

• The Responsible Person listed on the cosmetic label is legally obligated to maintain and update safety substantiation records.

• FDA may request access to these records during inspection, and they must be readily available.

• MoCRA grants FDA the authority to issue recalls if a cosmetic is found unsafe or adulterated.

• Safety substantiation must be updated if new scientific information or product changes arise.

What Our Service Provides

We offer a complete service to prepare your MoCRA-compliant safety substantiation dossier. Our deliverables include:

• A detailed review of your formulation and intended use

• Collection and evaluation of ingredient safety and toxicological data

• Exposure and risk modeling tailored to your product type

• Recommendations for any additional testing needed

• Preparation of a comprehensive Safety Substantiation Report summarizing the safety rationale and conclusions

• Creation of audit-ready documentation formatted for FDA inspection

Why This Matters

Strong safety substantiation is not only a legal requirement — it’s a cornerstone of brand credibility and consumer trust.

Proper documentation:

• Confirms your compliance with MoCRA and FDA expectations

• Minimizes the risk of regulatory action or recall

• Demonstrates your company’s commitment to product safety

• Builds confidence with distributors, retailers, and customers