The Modernization of Cosmetics Regulation Act (MoCRA) introduced new legal requirements for cosmetics manufacturers and brand owners selling products in the United States.
Every cosmetic product must now be accompanied by clear, well-organized documentation demonstrating that it safe , is properly labeled, was manufactured under hygienic conditions, and meets FDA requirements.

Our service for compiling a cosmetic product dossier for the US provides all the necessary documents, evidence, and structure you need to comply with MoCRA documentation standards—similar to the concept of the EU Product Information File (PIF), but adapted to U.S. regulations.

We create a complete, audit-ready dossier that ensures your brand is prepared for an FDA inspection or verification at any time.

What the U.S. product dossier contains

Each dossier is structured to cover the full scope of the FDA’s expectations under MoCRA:

1. Administrative and product identification

• Product name, function, and category

• Responsible person details (manufacturer, importer, or distributor)

• Assessment of product labeling, illustrations, and claims

• Facility registration references

2. Product composition

• Complete list of ingredients with INCI names and concentrations

• Documentation on ingredient sourcing and supplier data

• Restrictions and regulatory controls for each component

• Documentation on flavorings and fragrances where applicable

3. Safety data sheet

• Toxicological profile for each ingredient

• Exposure and risk assessment

• Margins of Safety (MoS) calculations

• Final safety justification

4. Production and quality information

• Description of production process and controls

• GMP compliance statement (aligned with FDA expectations and the principles of ISO 22716)

• Microbiological controls and batch traceability

• Data on quality testing and packaging compatibility

5. Data on stability and shelf life

• Summaries of stability and storage tests

• Packaging compatibility results

• Period After Opening (PAO) or shelf life justification

6. Compliance with labeling and claims

• Verification of product labeling to ensure compliance with FDA cosmetic labeling regulations (21 CFR 701).

• Verification of ingredient declarations, warnings, and product identity

• Review of marketing claims to ensure that no drug-like claims are made

7. Supporting documentation

• Certificates of Analysis (COA) and SDS for key ingredients

• IFRA, allergen, or fragrance documentation, if available

• Safety and performance test reports (optional)

• FDA notification confirmations (facility registration and product listing)

Why this dossier is important

Creating a structured dossier helps you:

• Demonstrate compliance with MoCRA and FDA regulations

• Maintain transparency and traceability throughout your supply chain

• Provide immediate access to documentation when the FDA requests an inspection

• Protect your brand against costly enforcement actions or recalls

• Build credibility with partners, distributors, and retailers

A complete dossier demonstrates that your company has exercised due diligence in the areas of safety, quality, and labeling—essential for access to the U.S. market.

Who needs this service

• European or international brands that export cosmetics to the United States

• U.S. manufacturers want to organize and standardize compliance documentation

• Private labelers and distributors that manage multiple product lines under a single responsible entity

• Regulatory consultants or importers acting as the responsible person under MoCRA

What you receive

• Complete U.S. Cosmetic Product Dossier in electronic format (PDF or Word)

• All documents indexed, cross-referenced, and stored in a logical structure

• Optional extensions for translations, updates, or additional formulations

• FDA-inspection-ready documentation and long-term archive version

Our process

1. Data collection – You provide product formulas, labels, and production data.

2. Compliance Review – We verify the completeness of data, labeling, and regulatory compliance.

3. Compiling the Dossier – Our team compiles the complete dossier and structures it according to MoCRA requirements.

4. Quality control & delivery – You will receive a complete, submission-ready file, along with a verification summary.

Why Choose Us

• Experts in cosmetics compliance in both the EU and the US

• In-depth knowledge of MoCRA, FDA labeling rules, and toxicological documentation

• Clear communication and a transparent process

• Professional, inspection-ready dossiers prepared by regulatory specialists