FDA Cosmetics MoCRA Facility Registration and Product Listing Support

MoCRA applicability and exemption review, facility registration, cosmetic product listing, responsible-person data and update support. Registration and listing do not mean FDA approval.

Service overview

MoCRA establishes U.S. cosmetic facility registration and product listing duties. The facility operator, responsible person named on the label, contract-manufacturing relationships and any small-business exemption must be assessed separately. SCS Testing supports preparation and validation of submission data but does not describe facility registration or product listing as FDA cosmetic certification; FDA does not issue a product approval certificate through this program.

Applicable products or businesses

• Domestic and foreign facilities manufacturing or processing cosmetics for the U.S. market
• Responsible persons whose names appear on cosmetic labels and their brand owners
• Businesses requiring initial registration/listing, updates, renewal or record reconciliation

Target market

• U.S. cosmetics market

Regulatory authority

• U.S. FDA cosmetics program

Regulations, directives and standards

• Modernization of Cosmetics Regulation Act of 2022
• FD&C Act provisions added by MoCRA for facility registration and product listing
• Current FDA guidance on Cosmetics Direct, SPL, exemptions and updates

Service scope

• Product/establishment role and exemption assessment
• Facility legal information, FEI and U.S. agent/contact review
• Product listing, ingredient, label and responsible-person data preparation
• Annual product updates, facility renewal and change-maintenance support

Service process

• Confirm cosmetic status and establishment activities
• Identify the facility, responsible person and possible exemptions
• Reconcile FEI, legal name, address, brands and formulation data
• Prepare facility-registration and product-listing submissions
• Retain confirmations and maintain annual/biennial and change-driven updates

Information required

• Facility legal name, address, FEI, activities and contacts
• U.S. agent information for foreign facilities
• Product name, category, brand, complete ingredients and label
• Responsible-person identity and contact information
• Existing registration, listing, SPL or Cosmetics Direct records

## Reports, certificates or registration outcomes Outcomes are facility registration and/or product listing submissions and supporting system records. FDA states that this is not a cosmetic approval program; registration or listing does not by itself establish formulation safety, label compliance or approval for sale.

Factors affecting timing

Timing depends on FEI matching, establishment roles, U.S. agent confirmation, ingredient data, SPL validation and system feedback. Any claimed exemption needs verifiable support.

Common compliance risks

• Promoting registration or listing as FDA approval/certification
• Incorrect facility, brand-owner, responsible-person or contract-manufacturing relationships
• Duplicate FEIs or inconsistent legal names and addresses
• Product listings are not updated after ingredient or label changes

Related services

• Cosmetics testing and safety evidence
• Cosmetic label and claim review
• FEI information support
• EU CPNP/CPSR document support

Information for an initial assessment

Provide the product name, model, intended use, target market, bill of materials and available reports so that the applicable route and evidence gaps can be assessed.