Facility registration
Organize information for cosmetic product facility registration, including establishment renewal every two years.
LexisNexis MoCRA Facility Registration & Cosmetic Product Listing Services
Compliance for Cosmetic ManufacturersMoCRA facility registration & listing servicesPrepare for FDA cosmetic facility registration and product listing, including recommended electronic SPL submissions.
What are LexisNexis MoCRA facility registration and cosmetic product listing services?
LexisNexis MoCRA Facility Registration & Listing Services is a regulatory services offering that helps manufacturers prepare facility registration and product listing submissions under MoCRA. It focuses on timing expectations and Structured Product Labeling (SPL) for electronic submissions.
MoCRA Requirements for Cosmetic Facility Registration & Product Listing
MoCRA Guidance and DefinitionsUnderstand what MoCRA requiresFDA draft guidance on MoCRA addresses early compliance requirements, including cosmetic product facility registration and listing. MoCRA was signed into law on December 29, 2022 and represents the first major change to cosmetics regulations since 1938.
Track MoCRA Deadlines, FDA Updates & Compliance Requirements
Registration and Listing TimelinesTrack deadlines and updatesMoCRA facility registration and product listing requirements included a first submission deadline of December 29, 2023, with FDA enforcement beginning in July 2024. Ongoing expectations include updates within 60 days of a change, annual product listing updates, and establishment renewal every two years.
Prepare MoCRA Electronic Submissions & SPL Compliance
Structured Product Labeling (SPL)Prepare for electronic submissionsFDA has stated it strongly encourages electronic submission of registration and product listing information to support efficiency and timeliness of data submissions and management. SPL is an HL7-approved XML standard for structured submissions, and LexisNexis Life Sciences has managed SPL submissions for vendors for over 15 years.
MoCRA Compliance Services for Registration & Product Listing
Services to support MoCRA workHere are the core tasks your team can align around for MoCRA facility registration, product listing, and SPL-based electronic submission planning.
Product listing
Capture product listing details and plan for annual product listing updates.
60-day updates
Track changes and update registration or product listing information within 60 days when required.
SPL XML preparation
Prepare Structured Product Labeling (SPL) as XML for electronic submission, which FDA strongly encourages for registration and listing. SPL is a standard approved by Health Level 7 (HL7).
MoCRA readiness survey
Use the MoCRA Readiness Survey to review documentation, standard operating procedures, complaints and recalls, and product data. The questions are intended to help gauge your strategy for compliance.
Expert appointment
Request an appointment with a subject-matter expert to talk through facility registration, product listing, and SPL questions.
Data Security, Privacy, and Governance
Security and privacy you can count onPrivacy by design
LexisNexis protects customer data wherever it is stored, sent, or accessed. We apply privacy by design principles at every stage of development to ensure security and compliance are built in from the start. Our advanced encryption and rigorous compliance protect your sensitive information.
Strict security protocols
LexisNexis systems meet the highest standards for information security. We partner with trusted, enterprise-grade cloud providers, continuously monitor and improve our infrastructure,
Who are LexisNexis MoCRA Facility Registration & Listing Services for?
If you’re a cosmetics company working through MoCRA facility registration and product listing requirements, LexisNexis Life Sciences can help you organize key timing expectations and SPL-related submission considerations. This service is intended for manufacturers, responsible persons, and regulatory compliance teams managing initial submissions, updates, and renewals.
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MoCRA Compliance & Cosmetic Regulatory Solutions FAQs
Frequently asked questionsCosmetic regulations vary by market. In the U.S., this includes MoCRA requirements such as facility registration and product listing, while in the EU it involves CPNP notifications and ingredient compliance. We help you navigate global requirements to ensure your products meet all applicable regulations.
Structured Product Labeling (SPL) is an XML-based format used by the FDA for product submissions. Under MoCRA, SPL is used for cosmetic product listings and facility registrations. We manage the creation, validation, and submission of SPL files to ensure compliance.
Yes. Under MoCRA, manufacturers and processors must register their facilities and list their cosmetic products with the FDA. Our team helps ensure accurate, timely submissions and ongoing compliance.
Cosmetic labeling must meet specific requirements for ingredients, claims, and formatting depending on the market. We provide guidance and validation to help reduce risk and avoid compliance issues.
We provide end-to-end support—from regulatory guidance and data structuring to SPL submission and ongoing updates—helping you streamline compliance and bring products to market with confidence.
Our expanded Regulatory Advisory Team can assist you with a wide variety of tasks and topics. Click on the Inquire Now button above or Choose Plan and fill out a few brief comments about your needs in order to facilitate an appointment. We look forward to learning more about how we can assist you.
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Explore Life Sciences Regulatory Compliance Solutions
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