A MoCRA file should start with the product, responsible person, facility, and U.S. market activity—not with a pile of certificates from unrelated markets.
1. Define the MoCRA scope
MoCRA addresses cosmetic facility registration, cosmetic product listing, safety substantiation, and serious adverse-event reporting. Facility registration generally concerns facilities that manufacture or process cosmetics. Product listing is handled by the responsible person: the manufacturer, packer, or distributor whose name appears on the product label. Applicability still depends on the product’s intended use, label, facility activity, and statutory exemptions.
2. Build the facility and responsible-person record
Keep one record for the facility name, address, FDA Establishment Identifier (FEI), manufacturing or processing activity, brand names, responsible person, U.S. agent when applicable, and change history. FDA states that facilities required to register generally renew every two years. Keep the current FDA instructions alongside the submission evidence and record any change that may require an update.
3. Match each product listing to the label
Create a separate product record for each cosmetic marketed in the United States. Link the product name, responsible person, ingredient information, label or package artwork, associated facility, and annual update record. A product listing is not FDA approval, and FDA does not issue a certificate for a facility registration or product listing. Do not describe a submission or listing as a certification result. Review whether a formula, fragrance, size, package, label, or responsible-person change requires an update.
4. Maintain safety substantiation and adverse-event records
Maintain a safety-substantiation index for each product: formula and ingredient information, relevant safety data, conditions of use, assessment rationale, label review, and document versions. MoCRA requires the responsible person to ensure and maintain records supporting adequate safety substantiation; FDA does not prescribe one fixed testing package for every cosmetic. Serious adverse events must be reported to FDA within the applicable statutory period, with the event record, product label, and later information retained and updated as required.
5. Human review before submission or update
Before submitting or updating, check whether the product is a cosmetic rather than a drug or another regulated product; whether facility, responsible-person, and label names match; whether ingredients and label versions agree; whether safety records trace to the correct product version; whether an exemption or additional requirement applies; and whether submission confirmations and ownership of future updates are archived. 绿色方舟（深圳）认证有限公司 recommends keeping formula, label, responsible-person, and facility changes in the same versioned register so that one submission is not presented as a permanent conclusion.
Sources and limits
This reference is based on public U.S. Food and Drug Administration materials on MoCRA, cosmetic facility registration and product listing, cosmetic safety, and serious adverse-event reporting. FDA guidance helps explain submission requirements; it does not replace a product-specific legal assessment.
