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    Worldover, AI operating system for chemicals and cosmetics companies

    A module inside Worldover's substance-aware operating system · United States

    MoCRA compliance, without the spreadsheet stack.

    The Modernization of Cosmetics Regulation Act is the first major federal overhaul of US cosmetics law in 80 years. Worldover's MoCRA module holds facility registrations, product listings, Responsible Person designations, adverse event records and safety substantiation as native data on the same record as formulation, production and EU CPNP filings, so a brand selling in both markets keeps one source of truth.

    Quick answer

    MoCRA compliance software for cosmetics manages the obligations introduced by the Modernization of Cosmetics Regulation Act of 2022: facility registration with the FDA, product listing with submission codes, designation of a Responsible Person, safety substantiation, adverse event records and labelling of fragrance allergens. Worldover holds each of these as structured data on the substance, the formula and the facility, then drafts and submits the filings, monitors changes to the FDA guidance and keeps Responsible Person records audit-ready.

    • Facility registration and biennial renewal
    • Product listings with FDA submission codes
    • Responsible Person designation per product
    • Adverse event records and 15-day reports
    • Safety substantiation pack on demand
    • Fragrance allergen labelling support

    Work email only to start. No calendar juggling, we come back within one business day.

    How this connects to Worldover

    Managing INCI, PIF, CPSR and CPNP across a growing product range?

    Worldover holds INCI, formulation, PIF, CPSR, CPNP, SCPN and MoCRA on one substance-first record, with Willow AI drafting and filing on your live data.

    See AI ERP for cosmetics

    What MoCRA actually requires

    MoCRA gives the FDA real authority over cosmetics for the first time. Every facility that manufactures or processes cosmetic products for the US market must register and renew every two years. Every product must be listed, with the Responsible Person on the label declared to the FDA. Every brand must hold safety substantiation that supports each product. Serious adverse events must be reported within 15 business days. Mandatory recall authority sits on top of all of it.

    In a spreadsheet stack, every one of these obligations is a separate file, a separate owner and a separate point of failure. The FDA does not care which spreadsheet is out of date. MoCRA was written assuming brands would build a real system of record. Most have not, and the audit risk compounds quietly.

    Why Worldover fits the MoCRA regime

    Worldover treats the substance, the formula, the facility and the product label as connected records. A facility registration is not a PDF, it is a structured entity linked to every product made there. A product listing is generated from the live formula, not retyped. A Responsible Person change updates every product they cover. Safety substantiation links to the underlying tox data, stability data and clinical evidence. When the FDA publishes new guidance, Willow flags the products affected and drafts the remediation.

    One operating system for US, UK and EU cosmetics

    Brands selling on both sides of the Atlantic do not want two systems, two data models and two audit trails. Worldover runs CPNP filings for EU markets, SCPN for the UK and MoCRA for the US from the same formula record. Change an ingredient once, every downstream filing is regenerated. Add a new market, the data is already there.

    Proof from the field

    Presperse, the US ingredient supplier serving major beauty brands, runs on Worldover for its regulatory documentation, customer-specific declarations and substance master. The same system extends naturally to brands managing MoCRA obligations end to end, with the regulatory team approving the work instead of typing it.

    The four MoCRA workstreams, and where each one fails

    WorkstreamClockUsual failure point
    Facility registrationBiennial renewal, 60 days for material changesA site move, a new brand made at the site or a US agent leaving the business, none of which start as regulatory events
    Product listingAnnual updateA supplier substitution changes the ingredient list months before anyone refiles
    Safety substantiationHeld on demand, continuouslyEvidence exists but sits across tox reports, stability files and supplier emails, so it cannot be produced quickly
    Adverse event reporting15 business days for serious events, records held 6 yearsReports arrive through customer service and never reach regulatory in time

    Worldover attacks all four the same way. The obligation is derived from live operational data, the clock is tracked against the record it belongs to, and the filing is drafted for a human to approve rather than assembled from scratch.

    MoCRA is four obligations on one dataset

    Registration, listing, safety substantiation and adverse events look like four workflows. They are four views of the same records: the facility, the formula, the label and the Responsible Person. Break them apart and each one drifts on its own schedule. Hold them together and a production transfer, an ingredient substitution or a brand acquisition raises every filing it implies, on the day it happens.

    The detail sits in two companion guides: FDA cosmetic facility registration covers who has to register and the biennial and 60-day clocks, and FDA cosmetic product listing requirements covers what each listing carries and what forces a refiling. For the Californian layer that sits on top for anything sold into that state, see California Proposition 65, and for chemical products in the US, TSCA compliance software.

    If your business sells primarily into the United States, Worldover in the US sets out how the whole operating system is shaped around MoCRA, FDA and state-level obligations rather than treating them as an export module.

    FAQs

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