The Modernization of Cosmetics Regulation Act (MOCRA) has reshaped the U.S. cosmetics landscape, establishing clear safety, documentation, and compliance expectations for all products marketed in the United States. Whether you are a new brand entering the U.S. market or an international company expanding your footprint, regulatory adherence to MOCRA is now a fundamental business requirement.
At CE.way, we offer a comprehensive suite of services designed to support every stage of MOCRA compliance—helping you mitigate risk, streamline registrations, and maintain regulatory integrity in the world’s largest beauty market.
Formula Compliance Review
A product’s formulation determines its regulatory pathway. Under MOCRA, all cosmetic ingredients must be evaluated for safety and legality.
Our Formula Review Service includes:
- Complete ingredient assessment against U.S. regulatory standards
- Identification of prohibited substances or restricted components
- Risk evaluation of preservatives, colorants, and additives
- Recommendations to reformulate for compliance or safety optimization
This early-stage review ensures that your products are compliant prior to listing them in the U.S. market.
Labeling Review and Claims Assessment
Labels are critical for both consumer communication and regulatory compliance. MOCRA requires accurate and truthful representation on all cosmetic labels.
Our Labeling Review Service covers:
- INCI-compliant ingredient declaration
- Required labeling elements including net quantity, distributor address, and country of origin
- Verification of warning statements or user instructions
- Claims substantiation to avoid regulatory concerns around misleading or therapeutic messaging
Proper labeling protects your brand and minimizes the risk of enforcement actions.
U.S. State-Level Cosmetic Regulations
In addition to federal MOCRA requirements, several U.S. states enforce their own additional cosmetic standards. For example:
- California Proposition 65 restricts exposure to certain chemicals
- States may impose unique heavy metal limits or labeling demands
Our specialists monitor state-level regulatory developments to ensure products comply not just federally—but regionally as well.
U.S. Responsible Person (RP) Support
Under MOCRA, every cosmetic product marketed in the United States must designate an official Responsible Person (RP). The RP carries regulatory accountability for compliance documentation and communication with authorities.
With our Responsible Person Support, CE.way assumes this role on your behalf, including:
- Reviewing submission and safety documentation
- Acting as official regulatory contact
- Handling inquiries from regulatory authorities
- Maintaining compliance records
This service is essential for international manufacturers without an established U.S. presence.
U.S. Agent Services for Foreign Entities
Non-U.S. companies must appoint a U.S. Agent to facilitate regulatory communication and compliance:
- Acts as a liaison with U.S. regulatory bodies
- Receives official correspondence
- Supports compliance during inspections or audits
CE.way’s U.S. Agent Service ensures proper representation under MOCRA and FDA expectations.
Product Listing Support
MOCRA mandates that all cosmetic products marketed in the United States be properly listed with regulatory authorities. Our Product Listing Service includes:
- Submission of product information and ingredient details
- Registration with relevant U.S. databases
- Responsible Person identification
- Recordkeeping and updates for regulatory traceability
Accurate and complete product listings help avoid enforcement actions and enable compliant market access.
Product Safety Substantiation and Toxicological Evaluation
Safety substantiation stands at the heart of MOCRA compliance. Regulatory authorities require documented evidence that a cosmetic product is safe for intended use.
Our Product Safety Substantiation Service provides:
- Comprehensive toxicological reviews
- Evaluation of ingredient interactions and exposure levels
- Compilation of a Safety Assessment Report
- Professional safety opinion based on industry standards
This substantiation is foundational for regulatory confidence and product liability protection.
Facility Registration with FDA
All facilities involved in the manufacturing, packaging, or distribution of cosmetics for the U.S. market must be registered:
- Manufacturer locations
- Product packaging facilities
- Distribution centers
CE.way assists with Facility Registration, ensuring:
- Correct classification of each site
- Submission to the U.S. Food and Drug Administration (FDA)
- Updates or renewals as needed
Proper facility registration prevents market access delays and improves regulatory transparency.
Why MOCRA Services Are Essential
MOCRA represents a significant modernization of U.S. cosmetic regulations by introducing structured requirements for:
- Product safety substantiation
- Facility registration
- Designated responsible parties
- Transparent ingredient and labeling standards
Non-compliance can result in warning letters, product detentions, recalls, or import refusals.
Partnering for U.S. Market Success
At CE.way, we understand that regulatory compliance is not just about meeting checkboxes—it’s about building a trusted and durable brand in the global cosmetics landscape. Our MOCRA services are tailored to support you through every compliance challenge, from formulation to launch and beyond.
With expert guidance, your cosmetic products can navigate the complexities of U.S. regulations and reach consumers with confidence, credibility, and compliance.
