MoCRA USA
Services
MoCRA USA Compliance Services FDA Cosmetic Registration & Listing Made Simple
Entering the US cosmetics market is now more regulated than ever.
Under the Modernization of Cosmetics Regulation Act (MoCRA), brands must meet strict FDA requirements for product listing, facility registration, and ongoing compliance.
gcrs group supports global brands with end-to-end MoCRA compliance, ensuring smooth entry into the US market, without delays, disruption, or regulatory risk.
What Is MoCRA Compliance?
MoCRA is a US regulatory framework that strengthens FDA oversight of cosmetic products.
It introduces mandatory requirements for:
- FDA cosmetic product listing
- Facility registration
- Safety substantiation
- Adverse event reporting
- Regulatory record-keeping
What’s changed?
Compliance is no longer optional; it is now enforced and business critical.
Why MoCRA Matters for Your Business
MoCRA directly impacts your ability to sell in the United States.
Without proper alignment, you risk:
- Product removal from the market
- Import holds or shipment delays
- FDA enforcement actions
- Loss of retailer or distributor confidence
✔ For global brands, compliance is not just regulatory, it’s essential for commercial success.
FDA Product Listing Requirements
All cosmetic products must be listed with the FDA via its electronic system.
Key requirements:
- Existing products listed within regulatory timelines
- New products listed within 120 days of market entry
- Annual updates required
- Submission via FDA Direct portal
Accurate listing ensures uninterrupted product availability in the US market.
Facility Registration Requirements
MoCRA also requires all manufacturing and processing facilities to register with the FDA.
Applies to:
- Manufacturers
- Contract manufacturers
- Processing facilities
Key obligations:
- Registration before market entry
- Biennial renewals
- Accurate operational details
✔ Facility registration is directly linked to product approvals and ongoing compliance.
MoCRA Requirements
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To stay compliant, brands must manage
Without proper alignment, you risk:
- Product listing and updates
- Facility registration and renewals Safety documentation
- Adverse event reporting systems
- Labelling compliance
- Regulatory record maintenance
These requirements align with broader global cosmetic compliance strategies, not standalone processes.
Our MoCRA Compliance Process
We simplify complex FDA requirements into a structured, scalable process:
How gcrs group Supports Global Compliance
What You Receive
Clear, compliance-ready deliverables:
- FDA product listing confirmation
- Facility registration confirmation
- Submission documentation
- Compliance tracking support
- Annual update management
✔ Everything structured for audit readiness and long-term compliance.
Who This Is For
Designed for businesses expanding into the US:
- Global cosmetic brands entering the US market
- Importers and distributors
- Manufacturers and contract manufacturers
- E-commerce and DTC brands
- Multi-market operators scaling internationally
✔ Focus: fast entry, reduced risk, and operational continuity
Risks of Non-Compliance
Failure to meet MoCRA requirements can lead to:
- FDA enforcement actions
- Product delisting or refusal
- Delays in market entry
- Supply chain disruption
- Commercial and reputational loss
Early alignment reduces risk and protects growth.
Integrated Global Support
MoCRA is not an isolated requirement, it must align with your wider regulatory strategy.
gcrs group connects US compliance with:
- Product registration services
- Cosmetic testing and validation
- Responsible Person services (EU/UK)
- Ongoing compliance management
✔ This ensures a single, scalable system across all markets
Global Expertise. Local Knowledge.
A regulatory partner that supports growth, not just compliance.
With gcrs group, you get:
Votre partenaire de confiance pour la conformité mondiale
Scale Your Products Globally with Confidence.
Frequently Asked Questions
MOCRA stands for the Modernization of Cosmetics Regulation Act — the new US law that governs cosmetic product requirements, safety, reporting and registration.
All cosmetic products imported to or sold in the USA — including skin care, hair care, makeup and personal care items — must comply with MOCRA requirements to legally enter the US market.
Compliance includes safety assessments, ingredient review, proper labelling, documentation (such as Product Information Files), registration or notification to US authorities, and adverse event reporting systems.
Yes. GCRS offers full MOCRA USA Services — managing documentation, safety files, labelling checks and submission to meet US regulatory requirements.
Testing requirements depend on the product and its ingredients. MOCRA mandates adequate safety evaluation, which may include toxicology, stability, and microbiological testing as needed.
A product that doesn’t comply may be denied market entry, recalled, or face legal/regulatory consequences in the United States.
Yes — GCRS can assist in evaluating existing products and updating regulatory files to ensure full MOCRA compliance for future US sales.
Provide your product formulation, ingredient list, packaging and target US launch plan. gcrs group will then guide you through compliance steps, documentation and registration processes.
Timelines vary by product complexity and documentation completeness. gcrs group works to streamline the process, but allow sufficient time for safety review, testing and submission.
MOCRA compliance ensures you have met US regulatory requirements — but final market acceptance can depend on labelling, claims, manufacturing standards, and ongoing post-market vigilance.