MoCRA Cosmetic Facility Registration: Who Registers and What Changed

MoCRA added cosmetic facility registration and product listing to section 607 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The two submissions have different owners: the facility owner or operator registers a covered manufacturing or processing facility; the manufacturer, packer or distributor whose name appears on the product label is the responsible person who lists a covered marketed product. Check the activity, product and exemptions before assuming either filing is required. Registration, listing and a submitted record are not FDA approval, certification or a promise of U.S. admission.

Who registers a cosmetic facility

An owner or operator generally registers a U.S. or foreign facility that manufactures or processes cosmetics for U.S. distribution, unless an exemption applies. A location that solely labels, relabels, packages, repackages, holds or distributes cosmetics is not a manufacturing/processing facility for this purpose merely because it handles the products; filling a product container is not treated as mere packaging for this exception. Drug and device facilities or products may be subject to different requirements. For a contract manufacturing facility, one facility registration can cover work for multiple responsible persons; a responsible person may submit it for the facility, so coordinate with the owner or operator rather than duplicating registrations. A foreign covered facility provides the U.S. agent information called for in its registration; that contact is not automatically the label-named responsible person. See FDA’s final guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products .

FEI, submission fields and deadlines

FDA uses its Establishment Identifier (FEI) as the facility registration number. First check whether the facility already has an FEI; reuse it if assigned and request one if needed before registration. DUNS may be supplied as optional information, but it is not the mandatory cosmetic facility identifier. Form FDA 5066 asks for the facility, owner/operator, U.S. agent for a foreign facility, brand and product-category information. A newly covered facility generally registers within 60 days of first manufacturing or processing cosmetics for U.S. distribution, subject to the statutory transition dates. A required facility registration is renewed every two years from its own initial registration date; required registration information changes generally must be amended within 60 days. The cosmetic cycle is not the October–December food renewal window. FDA’s current portal guidance is at https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products .

Which small businesses and products may be exempt

Certain small businesses whose average gross annual U.S. cosmetic sales over the previous three-year period are below the inflation-adjusted statutory threshold may be exempt from facility registration and product listing. Check the current statutory threshold and the entity’s actual sales; do not apply the exemption to facilities or responsible persons for products that regularly contact the mucous membrane of the eye, are injected, are intended for internal use, or alter appearance for more than 24 hours without customary consumer removal. Other activity- and drug/device-related exceptions also require individual review. An exempt cosmetic manufacturing facility may be identified by name and address in a product listing when it has no required registration number.

Product listing is a separate responsible-person task

The responsible person named on the label lists a covered marketed cosmetic product using Form FDA 5067 or an available electronic route. The listing identifies the product, category, ingredients, responsible person and applicable manufacturing/processing facilities. A permitted listing can cover products with identical formulations or variants differing only in color, fragrance, flavor or quantity of contents; a separate statutory filing for every commercial SKU is not universal. A newly marketed product is generally listed within 120 days, subject to the relevant statutory transition rules, and listing updates are provided annually. Facility-registration amendments have a separate clock. See https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products .

Other safety obligations and regulatory status

MoCRA also requires the responsible person to maintain adequate safety-substantiation records and to report a serious adverse event within 15 business days after receiving it, where the rule applies. Those records and reporting duties are distinct from the fields required for facility registration or product listing. FDA has been developing cosmetics GMP requirements; a proposal, draft or industry standard such as ISO 22716 is not the same as a final FDA cosmetics GMP rule. FDA’s Appendix B questions 20–22 about U.S. agents remain distributed for comment only in the December 2024 guidance. FDA does not issue a cosmetic registration/listing compliance certificate.

Keep U.S. and EU obligations separate

EU Cosmetic Product Safety Reports, Product Information Files, responsible-person duties and CPNP notifications serve different legal purposes from U.S. MoCRA registration and listing. A single document or filing does not automatically satisfy both markets. Check each product’s classification, label claims and applicable market before deciding which service or evidence is needed.

Practical preparation and service scope

Confirm the actual facility operator, manufacturing activities, existing FEI, product categories, label-named responsible person, possible exemption and existing FDA record before preparing a filing. FDABridge's $349 facility-registration service covers the filing only, when applicable; it requires an existing usable FEI and the appointed U.S. agent information for a covered foreign facility. FEI acquisition and first-year agent coverage are separate from that offer. The $449 Cosmetics Starter adds FEI acquisition and retains its stated first-year agent coverage. Product listing is a separate professional service with its own billing unit and permitted FDA grouping rules. Review scope at https://fdabridge.com/cosmetic-facility-registration , https://fdabridge.com/cosmetic-product-listing and https://fdabridge.com/cosmetics . Our service acknowledgement, FDA processing and regulatory compliance are separate outcomes.