Since the enactment of the Modernization of Cosmetics Regulation Act (MOCRA) in the United States, cosmetic product compliance has become more structured, transparent, and safety-focused. Brands entering or selling products in the U.S. must ensure adherence to MOCRA requirements, which align with global expectations for safety substantiation, labeling accuracy, ingredient transparency, and responsible party accountability.
At CE.way, we offer a comprehensive suite of MOCRA-aligned services to support cosmetic manufacturers, importers, and brand owners in navigating U.S. regulatory demands with confidence and efficiency.
Formula Review
Before a product enters the U.S. market, its formulation must be assessed for compliance with federal cosmetic laws and ingredient restrictions. Our formula review service includes:
- Evaluation of all ingredients against U.S. regulatory lists
- Identification of prohibited or restricted substances
- Verification of safe concentration levels for colorants, preservatives, and actives
- Strategic reformulation recommendations, when needed
This review minimizes regulatory risk and supports product safety before market entry.
Labeling Review
U.S. labeling requirements under MOCRA are strict and detailed, covering everything from ingredient declaration to claims substantiation. Our labeling review service ensures that:
- Ingredient listings comply with INCI (International Nomenclature Cosmetic Ingredient) standards
- Required labeling elements (net quantity, distributor information, country of origin, warnings) are present
- Claims are supported by safety data to avoid misbranding or enforcement action
Labels reviewed by our regulatory experts are positioned to meet FDA expectations and reduce risk of compliance issues or market withdrawal.
U.S. State Cosmetic Legislations
In addition to federal MOCRA requirements, individual U.S. states may have their own cosmetic compliance laws—especially around sensitive ingredients, trace metals limits, and labeling standards. Our specialists assess product portfolios for:
- State-specific restrictions (e.g., California Proposition 65)
- Heavy metal limits and trace contaminant standards
- Regional reporting obligations
- Variations in cosmetic definitions
This service helps brands anticipate and manage compliance on both national and state levels.
U.S. Responsible Person Support
Under U.S. regulatory law, every cosmetic product marketed in the United States must designate a Responsible Person—an entity accountable for ensuring regulatory compliance and acting as the official contact for authorities.
CE.way can serve as your U.S. Responsible Person, managing:
- Submission of product and safety information
- Accountability for compliance verification
- Liaison with regulatory authorities
- Recordkeeping and compliance documentation
This service is essential for foreign manufacturers without a U.S. establishment.
U.S. Agent Service
For companies based outside the United States, a U.S. Agent is a regulatory requirement. This service includes:
- Official address and point of contact for regulatory correspondence
- Assistance with FDA communications
- Support during inspections or compliance inquiries
Our agent service ensures proper representation and regulatory reliability within the U.S. market.
Product Listing
Under MOCRA, enrolling products in the U.S. FDA cosmetic product listing system is a mandatory step. CE.way handles:
- Submission of product details
- Ingredient disclosures
- Responsible Person identification
- Recordkeeping of U.S. listings
Product listings ensure that authorities have accurate and up-to-date data on all cosmetic products marketed in the U.S.
Product Safety Substantiation
MOCRA requires that every cosmetic product marketed in the U.S. is supported by a product safety substantiation—meaning there is documented evidence that the product is safe under labeled or customary conditions of use.
Our safety substantiation services include:
- Toxicological review of formulation
- Safety assessment by qualified professionals
- Documentation of safety endpoints (irritation, sensitization, systemic exposure)
- Compilation of a Safety Assessment Report for regulatory records
These substantiation reports form the scientific foundation that supports product safety compliance.
Facility Registration
All facilities involved in cosmetic manufacturing, packaging, labeling, or storage that supply products to the U.S. must be registered under MOCRA requirements.
CE.way supports:
- Facility listing with the U.S. Food and Drug Administration (FDA)
- Proper classification of manufacturing and processing sites
- Updates to registration information
- Assistance with FDA queries related to facility data
Proper facility registration helps ensure uninterrupted market access and regulatory transparency.
Why MOCRA Compliance Matters
MOCRA represents a significant evolution in U.S. cosmetic law by requiring:
- Comprehensive product safety substantiation
- Mandatory product and facility registration
- Explicit accountability via a Responsible Person
- Enhanced labeling and ingredient review standards
Non-compliance can result in product holds, detentions, recalls, warning letters, or import refusals.
Partnering with CE.way means accessing expert guidance that aligns your products with both current MOCRA standards and broader U.S. regulatory expectations. Whether you’re launching a single SKU or a global portfolio, our MOCRA services are designed to reduce risk, streamline compliance, and accelerate market entry into one of the world’s largest cosmetic markets.
