MoCRA Cosmetics Compliance

If your brand imports cosmetics into the United States from China or elsewhere in Asia, a lipstick, a serum, a mascara, a body cream, a colour foundation, a fragrance mist, a nail polish, MoCRA applies to you. Not to your Chinese contract manufacturer alone, not to your US Agent alone, but to your company, the responsible person whose name appears on the label. This guide is written for sourcing managers and brand founders who need to know, in 2026, what MoCRA actually requires today, what has been officially delayed by FDA, and what can be done inside a Chinese or Asian cosmetics facility to be ready when FDA eventually finalises its GMP standard.

What Is MoCRA and Why It Matters for Cosmetics Importers

MoCRA, the Modernization of Cosmetics Regulation Act of 2022, is the US federal law that gives FDA new authority over cosmetics. It was signed on 29 December 2022 as part of the Consolidated Appropriations Act 2023, and it amends sections 601 to 613 of the Federal Food, Drug, and Cosmetic Act. It is the first substantive update to US cosmetics regulation since 1938.

MoCRA introduced facility registration, product listing, safety substantiation records, adverse event reporting, FDA records access, mandatory recall authority, and a future GMP rule for cosmetic manufacturers and importers. It does not cover cosmetics that are also regulated as over-the-counter drugs, such as SPF-labelled sunscreens or fluoride toothpaste with an active ingredient; those stay under the separate OTC drug framework.

The point that causes the most confusion for importers: your Chinese supplier is not automatically the duty holder. The responsible person, the manufacturer, packer, or distributor whose name appears on the label, carries most of the obligations. For a typical US brand importing finished cosmetics, that is the US brand itself, not the contract manufacturer. The Chinese facility still has its own separate duty to register with FDA if it manufactures for the US market, but the product-level obligations sit with the label-holder.

MoCRA Timeline: Signed 2022, Enforcement Rolled Out 2023 to 2025

MoCRA was signed on 29 December 2022. Most of its substantive provisions took effect exactly one year later, on 29 December 2023: safety substantiation records, adverse event reporting, professional use labelling, and mandatory recall authority all became active on that date.

Facility registration and product listing were also due on 29 December 2023, but FDA granted a six month enforcement delay, and enforcement of those two requirements actually began on 1 July 2024. The GMP rule, the fragrance allergen labelling rule, and the talc and asbestos testing rule were all meant to follow on a statutory schedule, and all three have slipped.

Date	What happened or applies
29 December 2022	MoCRA signed into law
29 December 2023	Safety substantiation, adverse event reporting, professional use labelling, mandatory recall all in force
29 June 2024	Statutory deadline for fragrance allergen proposed rule (missed)
1 July 2024	Facility registration and product listing enforcement begins, after a six month FDA delay
29 December 2024	Statutory deadline for GMP proposed rule (missed)
28 November 2025	Talc and asbestos testing proposed rule withdrawn for republication
29 December 2025	Statutory deadline for GMP final rule (missed); FDA's PFAS in cosmetics report published on schedule
March 2026	Talc and asbestos testing final rule targeted
May 2026	Fragrance allergen proposed rule targeted
Ongoing 2026	Biennial facility registration renewal cycle active

The law itself is in force. What has slipped is the GMP rule, the most operational piece for a factory floor. Many brands assume MoCRA compliance is on hold because the GMP rule is delayed; it is not. Safety substantiation and adverse event reporting have been enforceable since December 2023.

Facility Registration: What FDA Requires and Who Files It

Every facility that manufactures or processes a cosmetic product for the US market must register with FDA, including contract manufacturers and foreign facilities in China, Vietnam, India or elsewhere. As of the most recent FDA summary data, dated 31 March 2026, there were 15,309 unique active facility registrations on file.

Registration can be filed electronically through the Cosmetics Direct portal, which has been live since 18 December 2023 and uses FDA's Structured Product Labeling format, or on paper using Form FDA 5066. A foreign facility must designate a US Agent as FDA's point of contact for regulatory communications and inspections; AQF coordinates with FDA-registered US Agents as part of a factory readiness engagement, without acting as the Agent itself.

Registration must be renewed every two years under section 607(a)(2) of the FD&C Act, and an abbreviated renewal is available under section 607(a)(5) when nothing has changed since the previous submission. The important split for importers to understand: the Chinese factory registers its own facility; the US brand separately lists its own products, covered next.

Product Listing: Cosmetics Direct and the Annual Update Rule

Every cosmetic product placed on the US market must be listed with FDA by the responsible person, generally the US brand or importer, not the contract manufacturer. As of 31 March 2026, FDA recorded 1,102,092 unique active product listings.

Listing covers product name, ingredient list, category, whether it is for professional or consumer use, and responsible person contact details, filed through the same Cosmetics Direct portal or on paper using Form FDA 5067. A new product must be listed within 120 days of first being sold in US commerce, and existing listings must be updated at least annually, or sooner if the formula changes.

This is where a factory-side gap often opens. If a contract manufacturer changes a raw material supplier without telling the brand, the FDA listing no longer matches what is actually being produced. That mismatch is a real compliance exposure if FDA ever inspects or requests records, since it can support a finding that the product is not what was declared.

Safety Substantiation: The New Records Requirement

Since 29 December 2023, the responsible person must ensure and maintain records supporting adequate safety substantiation for each cosmetic product. FDA does not mandate a specific test method, but the underlying data has to be scientifically robust and available on request.

What typically counts: toxicological data on ingredients, in-vitro testing, historical use data, published literature, stability testing, microbial testing, and packaging migration testing, the last of which overlaps with AQF's cosmetic packaging guide. For an importer sourcing in Asia, the practical task is making sure the contract manufacturer actually hands over certificates of analysis for raw materials, stability study results, microbiological testing, and packaging compatibility data, not just a finished product spec sheet. Without those records behind it, a safety substantiation claim does not hold up. AQF coordinates the relevant testing through ISO 17025 accredited third-party laboratories that AQF coordinates with, alongside AQF's own US compliance lab testing service.

Adverse Event Reporting: 15 Business Days to Notify FDA

The responsible person must report any serious adverse event to FDA within 15 business days, together with a copy of the retail packaging label. A serious adverse event includes death, a life-threatening experience, hospitalisation, significant disability, a congenital anomaly, an infection, significant disfigurement such as second or third degree burns, hair loss or persistent rashes, or any event requiring medical intervention to prevent one of the above.

Records of adverse events must be kept for six years, or three years for eligible small businesses. If new information comes in within a year of the original report, an update must go to FDA within 15 business days as well. This has been in force since 29 December 2023, and FDA's public adverse event monitoring dashboard makes these reports queryable.

For importers, this means consumer complaints reaching the brand need a written triage process against the "serious" threshold, and the contract manufacturer needs to be part of that process for root cause analysis and batch traceability, since the factory usually holds the production records that explain what happened.

GMP Rule Status: Why the Federal Standard Is Delayed and What to Do

The MoCRA GMP rule, RIN 0910-AJ00, has been reclassified in FDA's Unified Agenda as a Long-Term Action with the proposed rule listed as "to be determined". Both statutory deadlines have been missed, the proposed rule was due 29 December 2024, the final rule 29 December 2025, and FDA does not expect to publish a proposed rule within the next 12 months.

In the meantime, FDA has a non-binding Draft Guidance for Industry on cosmetic GMP, and the future rule is expected to live in 21 CFR part 711. Careful importers are not waiting. They are adopting ISO 22716, the international voluntary GMP standard already required in the EU under Regulation (EC) 1223/2009 and widely used across ASEAN and Korea, as the interim benchmark; see AQF's ISO 22716 cosmetic GMP guide for the full standard. They are also running gap assessments against personnel, premises, equipment, raw materials, production, quality control, deviations, complaints, recalls, and documentation, tightening supplier qualification and quality agreements, and digitising batch records so they are not a liability if FDA does inspect.

One point matters regardless of the delay: the FD&C Act's adulteration provisions still apply. FDA can treat a cosmetic as adulterated, meaning it cannot legally be sold, if manufacturing conditions are insanitary, GMP rule or no GMP rule. A delayed rule is not a pause on enforcement.

AQF's GMP-trained auditors mimic FDA inspection protocols for MoCRA-ready facility assessments in China and Asia, working against the ISO 22716 framework while the federal rule remains pending.

Fragrance Allergen Labelling and Talc and Asbestos Testing: The Other Pending Rules

Two more MoCRA-mandated rules are also behind schedule, though both remain live on FDA's agenda rather than shelved.

Fragrance allergen labelling, RIN 0910-AI90, missed its statutory deadline of 29 June 2024 and is now targeted for a proposed rule in May 2026. Until a final rule exists, US labels can keep grouping fragrance ingredients under the generic term fragrance. Brands sourcing scented products from Asia should start collecting updated allergen data and fragrance house certificates now, so relabelling is fast once the list is finalised, and should expect eventual alignment with the EU's existing allergen disclosure list.

Talc and asbestos testing, RIN 0910-AI82, had a proposed rule published in December 2024, which FDA withdrew on 28 November 2025, apparently for republication, with a final rule now targeted for March 2026. The expected approach uses standardised methods, polarised light microscopy and transmission electron microscopy, to detect asbestos in talc-containing cosmetics. Non-compliance would likely support an adulteration finding. Importers using talc should pre-qualify test capability with an ISO 17025 accredited laboratory and build the recordkeeping now rather than after the rule lands.

Children's cosmetics deserve a separate note: a child's makeup or bath product can trigger both MoCRA and CPSIA obligations depending on lead content and other factors; see AQF's CPSIA compliance guide for that overlap. Brands selling into California also need to track Proposition 65 warning label requirements, which run alongside MoCRA rather than replacing it; see AQF's Prop 65 compliance guide for that comparison.

Responsible Person vs US Agent vs Contract Manufacturer: Who Does What

This is the single most common point of confusion for brands importing cosmetics from China.

Role	Who it usually is	What they are responsible for under MoCRA
Responsible person	The manufacturer, packer, or distributor whose name is on the label, usually the US brand for imported cosmetics	Product listing, adverse event reporting, safety substantiation records, labelling compliance, recalls
US Agent	A US-based contact designated by a foreign facility	Being FDA's point of contact for that facility, including registration and inspection coordination; not liable for product-level obligations
Contract manufacturer	The factory in China or elsewhere that makes the product	Registering its own facility with a US Agent designated, following GMP once the rule is final, cooperating on safety substantiation records
US brand or importer	The company selling under its own name in the US	Usually acts as the responsible person, and oversees the contract manufacturer's GMP readiness

The mistake to avoid: appointing a US Agent for facility registration does not cover product-level MoCRA duties. Product listing and adverse event reporting sit with the label-holder, not with the facility's US Agent. For comparison, the EU's own Responsible Person concept under Regulation (EC) 1223/2009 is older and more document-heavy, requiring a single EU-established entity to hold a Product Information File; MoCRA's version is newer and more distributed across manufacturer, packer or distributor. A brand selling in both markets is better off designing one combined workflow than running two separate ones.

AQF's MoCRA-Ready Factory Audit Workflow in China and Asia

AQF is not a US Agent, and AQF is not a testing laboratory. AQF is the QC firm physically present inside the Chinese or Asian cosmetics factory, at the point where most of MoCRA's practical evidence actually gets generated.

The work runs in five steps. First, pre-audit facility mapping: raw material sources, subcontractor disclosure, batch traceability, water systems, environmental controls and existing quality documentation. Second, an on-site GMP audit, where AQF's GMP-trained auditors mimic FDA inspection protocols against the ISO 22716 framework, covering personnel, premises, equipment, raw materials, production, quality control, deviations, complaints and documentation. Third, sample-to-batch chain of custody supervision during the production run being shipped, with samples sealed and tracked to ISO 17025 accredited third-party laboratories that AQF coordinates with for heavy metals, microbial contamination, and talc or allergen testing where relevant. Fourth, a technical review of the lab report against MoCRA-relevant thresholds, flagging anything out of range. Fifth, a pre-shipment inspection confirming the shipped batch matches what was sampled and tested, checking markings, batch codes and label compliance.

The continuity from sample to batch is what most consultants cannot offer. A US Agent handles FDA paperwork. A laboratory tests whatever sample arrives at its door. Neither is physically in the factory when the production run is packed. AQF is, which is what turns MoCRA compliance from a documentary exercise into an operational one.

Frequently Asked Questions

What is MoCRA?

MoCRA, the Modernization of Cosmetics Regulation Act of 2022, is the US federal law giving FDA new authority over cosmetics. Signed on 29 December 2022 as part of the Consolidated Appropriations Act 2023, it amended sections 601 to 613 of the Federal Food, Drug, and Cosmetic Act, introducing facility registration, product listing, safety substantiation, adverse event reporting, mandatory recall, and a future GMP rule.

When did MoCRA take effect?

MoCRA was signed on 29 December 2022. Most substantive provisions took effect on 29 December 2023, including safety substantiation records, adverse event reporting and mandatory recall authority. Facility registration and product listing enforcement began on 1 July 2024, after a six month FDA delay.

Is the MoCRA GMP rule in force yet?

No. The GMP rule has been reclassified as a Long-Term Action on FDA's Unified Agenda, with the proposed rule stage listed as to be determined. Both statutory deadlines have been missed, proposed by 29 December 2024 and final by 29 December 2025, and FDA does not expect to publish a proposed rule within the next 12 months. Importers should follow ISO 22716 as the interim standard.

Who is the responsible person under MoCRA?

The responsible person is the manufacturer, packer, or distributor whose name appears on the product label, as defined in section 609(a) of the FD&C Act. For an imported cosmetic, this is usually the US brand or importer, not the Chinese factory. The responsible person carries obligations for product listing, adverse event reporting, safety substantiation records, and recalls.

Do I need a US Agent for MoCRA?

Yes, if your manufacturing facility is outside the United States. MoCRA requires a foreign facility to designate a US Agent as FDA's point of contact for registration and inspections. The US Agent is not the same as the responsible person; a Chinese factory needs a US Agent for its facility registration, while the US brand separately handles the product-level responsible person duties.

Do small businesses have to comply with MoCRA?

Businesses with average gross annual US cosmetic sales under one million dollars over the prior three years are exempt from facility registration, product listing, and the future GMP rule. The exemption does not apply to products that regularly contact the mucus membrane of the eye, are injected, are intended for internal use, or alter appearance for more than 24 hours.

How do I register a cosmetic facility with FDA under MoCRA?

Register electronically through the Cosmetics Direct portal, live since 18 December 2023, using the Structured Product Labeling format, or on paper using Form FDA 5066. Registration must be renewed every two years under section 607(a)(2) of the FD&C Act, with an abbreviated renewal available under section 607(a)(5) if nothing has changed.

What must be reported as a MoCRA adverse event?

A serious adverse event must be reported to FDA within 15 business days, with a copy of the retail label. This covers death, a life-threatening experience, hospitalisation, significant disability, a congenital anomaly, infection, significant disfigurement, or any event requiring medical intervention to prevent one of these outcomes. Records must be kept for six years, or three years for eligible small businesses.

When will FDA propose the fragrance allergen labelling rule?

FDA's Unified Agenda targets a proposed rule in May 2026, well past MoCRA's original statutory deadline of 29 June 2024. Until a final rule exists, US labels can continue to group fragrance ingredients under the generic term fragrance. Brands sourcing from Asia should collect allergen data and fragrance house certificates now to be ready to relabel.

How does MoCRA compare to EU cosmetics regulation?

The EU's Regulation (EC) 1223/2009 requires ISO 22716 GMP, notification through the CPNP portal, and a Product Information File held by an EU Responsible Person, a stricter and older framework than MoCRA. MoCRA introduces facility registration, product listing, safety substantiation, adverse event reporting, and a still-delayed GMP rule. Brands selling in both markets should build one combined compliance workflow rather than two separate ones.