Crossing the Atlantic with your cosmetic brand looks tempting: an enormous market and, historically, famously light regulation. That reputation is now out of date. If you want to sell cosmetics USA MoCRA compliance is the first hurdle you have to clear — the Modernization of Cosmetics Regulation Act of 2022 delivered the biggest change to United States cosmetic law in more than eighty years, handing the Food and Drug Administration (FDA) real oversight of a market that used to sit almost entirely outside its reach.
This guide is written for an EU or UK brand looking west. It explains what MoCRA actually requires — FDA facility registration, product listing, a named “responsible person”, safety substantiation, adverse-event reporting and the Good Manufacturing Practice and fragrance-allergen rules still being drafted — and then maps each obligation against the EU system you already know, so you can see clearly what transfers, what is genuinely new, and where the two markets part company.
Key takeaways
- MoCRA (2022) is the first major overhaul of US cosmetics law since 1938 and gives the FDA new powers over facilities, products and recalls.
- Two core duties: facility registration for manufacturers and processors, and product listing of each cosmetic and its ingredients with the FDA.
- The US “responsible person” is the manufacturer, packer or distributor named on the label — they must hold safety substantiation and report serious adverse events.
- There is no CPNP-style pre-market notification and no EU-style CPSR in the USA, and no general pre-market approval — except colour additives and OTC drugs.
- Sunscreens are regulated as over-the-counter (OTC) drugs in the US, not cosmetics — a critical trap for EU brands.
- GMP rules and a fragrance-allergen labelling rule are still being developed by the FDA; watch for the final texts.
What MoCRA changed for the US market
For most of the twentieth century, US cosmetics were governed by a handful of thin provisions in the Federal Food, Drug, and Cosmetic Act of 1938. Products did not have to be registered, the FDA could not compel a recall, and there was no legal obligation to report that a product had harmed someone. Compared with the EU’s detailed, pre-market framework, the American system was strikingly hands-off.
MoCRA — enacted at the end of 2022 as part of a wider appropriations package — closed much of that gap. It introduced mandatory facility registration and product listing, put safety substantiation and adverse-event record-keeping on a statutory footing, gave the FDA mandatory recall authority for the first time, and directed the agency to write new rules on Good Manufacturing Practice and fragrance-allergen labelling. It remains lighter than the EU regime in several respects, but “unregulated” is no longer accurate. If the US is your next step after Europe, keep the EU route to market in mind — many US concepts are variations on ideas you already meet there.
FDA facility registration: who must register
The first pillar of MoCRA is facility registration. Every facility that manufactures or processes cosmetic products for distribution in the United States must register with the FDA, whether that facility is in Ohio or in your home market in Europe. A contract manufacturer that makes product destined for US shelves is caught just as much as a brand’s own plant.
Registration is not a one-off. Facilities renew on a recurring cycle (every two years) and update their information when key details change. The FDA built a dedicated electronic system — branded “Cosmetics Direct” — to receive both registrations and product listings. Importantly, MoCRA did not introduce user fees for cosmetic registration or listing, so unlike the drug pathways this step does not carry an FDA charge.
Not every business has to register. The Act carves out an exemption for certain small businesses whose average gross annual cosmetic sales fall below a threshold set in the legislation — but that relief is withdrawn for higher-risk products (for example those that are injected, intended for internal use, or applied near the eye or to mucous membranes). If you rely on the small-business exemption, confirm your products do not fall into one of those excluded categories.
Note: Facility registration is about who makes the product; product listing is about the product itself. They are separate submissions with different information, even though a single responsible person often files both through the same FDA portal.
Product listing: every product, every ingredient
The second pillar is product listing. The responsible person must submit a listing to the FDA for each marketed cosmetic product, including a list of its ingredients, and keep that listing current with periodic updates. Where the EU asks for one notification per product through the CPNP portal, the US listing plays a broadly similar cataloguing role — but it is a post-market listing, not a gate you must pass through before the product can be sold.
That distinction matters. In the EU, notification on the CPNP database is a genuine pre-market step: the product cannot lawfully be placed on the market until it is done. The US listing is an obligation you must meet, but it does not function as pre-clearance. There is no FDA “approval number” for a general cosmetic, and no one at the agency reviews and signs off your formula before launch. The listing simply makes the FDA aware of what is on the market and what it contains.
For an EU brand, the practical upshot is that the data you assembled for CPNP — your full ingredient list, product category and formulation details — is largely the same raw material you will need for a US listing. The container and the deadlines differ; the underlying product knowledge does not.
The US “responsible person”: safety and adverse events
MoCRA introduces a “responsible person”, and although the label sounds like the EU role, the definition is different. In the US, the responsible person is the manufacturer, packer or distributor whose name appears on the product label. There is no requirement that this entity be a specialist regulatory representative, and — unlike the EU — no requirement that it be locally established for the role to exist, though a business selling into the US will in practice need a US-facing commercial presence or importer.
The US responsible person carries three key duties. First, they must ensure and maintain records demonstrating adequate substantiation of safety for each product — evidence that it is safe under labelled or customary conditions of use. Second, they must maintain records of health-related adverse events. Third, they must report serious adverse events to the FDA within a set window (15 business days), along with any new medical information for a period afterwards.
Here is the nuance an EU brand must not miss: MoCRA requires safety substantiation, but it does not prescribe a single mandated format the way the EU mandates the Cosmetic Product Safety Report. There is no US CPSR. That said, the safety dossier you already hold for Europe is the strongest possible evidence of substantiation you could bring to the US — which is exactly why getting the EU work right first pays off twice.
Warning: Do not assume a US “responsible person” is the same job as an EU Responsible Person. The EU role is a legally established entity inside the EU or Northern Ireland that holds the Product Information File and answers to competent authorities. The US role is simply the manufacturer, packer or distributor named on the label. Same phrase, materially different obligations — treat them as two separate appointments.
GMP, fragrance allergens and the rules still in motion
Two important MoCRA requirements are not yet fully written, and an EU brand should track both because it already meets the substance of them at home.
Good Manufacturing Practice
MoCRA directs the FDA to establish binding Good Manufacturing Practice regulations for cosmetics. At the time of writing the agency is still developing this rule. If your EU production already follows recognised cosmetic GMP (the ISO 22716 standard that underpins EU practice), you are well positioned — but you will need to check your operations against the final US text once it is published, because the two need not be identical. Our deep dive into GMP covers the principles that carry across both markets.
Fragrance-allergen labelling
MoCRA also directs the FDA to issue a rule requiring specified fragrance allergens to be named on the label. This too is still in development. The EU has already travelled this road with Regulation (EU) 2023/1545, which expands the list of allergens that must be declared to around eighty named substances. The US list, format and deadlines will be set by the FDA’s own rule and should not be assumed to match the EU’s — but a brand that has done the EU allergen work will find the underlying analysis of its fragrance house data directly reusable.
EU vs US: what transfers and what is new
The fastest way to orient an EU brand is a side-by-side comparison. The table sets the two systems against each other on the points that decide your documentation and launch plan.
| Requirement | EU (Regulation (EC) No 1223/2009) | USA (MoCRA / FD&C Act) |
|---|---|---|
| Pre-market notification | Mandatory CPNP notification before the product is placed on the market (Article 13). | No pre-market notification. FDA product listing is required, but as a post-market listing, not a gate. |
| Safety report / dossier | CPSR mandatory (Annex I, Parts A & B; Article 10), signed by a qualified safety assessor, held in the PIF. | No mandated CPSR format. The responsible person must hold adequate safety substantiation records. |
| Responsible person | An entity established in the EU/NI, named on the label, holding the PIF and answerable to authorities. | The manufacturer, packer or distributor named on the label; keeps adverse-event records and reports serious ones. |
| Registration / listing | No facility registration for cosmetics; compliance evidenced via the RP, PIF and CPNP. | Facility registration (manufacturers/processors) plus product listing of each product and its ingredients. |
| Sunscreens | Cosmetic; UV filters must be authorised under Annex VI. | Regulated as an OTC drug, not a cosmetic — a different, stricter pathway. |
| Authority | National competent authorities and market-surveillance bodies of each member state. | The FDA (federal), with new mandatory recall power under MoCRA. |
Two contrasts deserve emphasis. First, there is no general pre-market approval in the US for ordinary cosmetics — the FDA does not vet and license your formula before sale. The exceptions are colour additives, which do require pre-market approval, and OTC drugs, which follow their own approval route. Second, the definitions that separate a “cosmetic” from a “drug” are drawn differently on each side of the Atlantic — and nowhere is that sharper than with sun protection.
Sunscreens and product claims: where the US line moves
In the EU, a sunscreen is a cosmetic: its SPF is a cosmetic claim and its UV filters are controlled through Annex VI. In the United States, sunscreen is an over-the-counter drug. That single reclassification changes everything — active ingredients, testing, labelling (“Drug Facts” panel) and the regulatory pathway all follow drug rules, not cosmetic ones. An EU brand cannot simply relist a European sunscreen as a US cosmetic; it enters a different regime entirely. If your range sits anywhere near this line, our guide on classifying a product as cosmetic, medicinal or biocide shows how borderline decisions are reasoned, and the same care applies when you cross into US drug territory.
Claims are the other place the US line moves. In both markets, saying a product treats, prevents or alters a body function pushes it out of “cosmetic” and into “drug” — the EU polices this through Article 20, the US through the drug definition in the FD&C Act. Before a transatlantic launch, our overview of what cosmetic claims are allowed in the EU is a useful discipline: the instinct it builds — keep claims cosmetic, not medicinal — protects you on both sides.
Bringing it all together
MoCRA has moved the US from a market with almost no cosmetic oversight to one with real, FDA-enforced obligations: register your facility, list your products, name a responsible person, hold your safety substantiation, and report serious adverse events — with GMP and fragrance-allergen rules still to land. For an EU or UK brand, none of this is alien. It is a different container for information you already gather, plus a few genuinely new steps and one big reclassification to watch: sunscreens as drugs.
The most efficient way to prepare for the US is, perhaps counter-intuitively, to get your EU house fully in order first. A complete European dossier — safety assessment, ingredient data, allergen work, GMP evidence — is the strongest foundation for a US listing and safety substantiation, because the underlying science is shared. Lexora’s Full Compliance Pack pulls that European foundation together in one place, so that when you expand west the substantive work is already done and you are adapting it to MoCRA rather than starting again.
Frequently asked questions
Do I need FDA approval to sell cosmetics in the USA?
No — ordinary cosmetics do not need FDA pre-market approval in the USA. Under MoCRA you must register your manufacturing facility and list each product with the FDA, and the responsible person must hold safety substantiation, but the agency does not review and approve your formula before sale. The exceptions are colour additives and OTC drugs (including sunscreens), which do require FDA approval through their own pathways.
Is MoCRA the same as the EU Cosmetics Regulation?
No. MoCRA introduces facility registration, product listing, a named responsible person, safety substantiation and adverse-event reporting, but it has no CPNP-style pre-market notification and no mandated safety report. The EU’s Regulation (EC) No 1223/2009 is stricter and front-loaded, requiring a signed CPSR and CPNP notification before you can sell. Meeting one does not automatically satisfy the other, though the underlying product data overlaps heavily.
Do I need a CPSR to sell cosmetics in the USA?
Not in the EU’s mandated format. The US does not require a Cosmetic Product Safety Report; instead, the responsible person must keep records showing adequate safety substantiation for each product. In practice, an EU CPSR is excellent evidence of that substantiation, which is why brands expanding from Europe are already well placed on the safety front.
Are sunscreens cosmetics in the USA?
No — in the USA sunscreens are regulated as over-the-counter (OTC) drugs, not cosmetics, which is the opposite of the EU where they are cosmetics. That means different active-ingredient rules, testing and a “Drug Facts” label. An EU sunscreen cannot simply be listed as a US cosmetic; if your product makes SPF or sun-protection claims, check its classification carefully using our guide to cosmetic vs medicinal vs biocide thinking.
Who is the “responsible person” under MoCRA?
Under MoCRA the responsible person is the manufacturer, packer or distributor whose name appears on the product label. They must maintain safety substantiation and adverse-event records and report serious adverse events to the FDA. This is a different concept from the EU Responsible Person, which must be established in the EU or Northern Ireland and hold the Product Information File — so if you sell in both markets you need to satisfy each definition separately.
Does facility registration cost a fee with the FDA?
MoCRA did not introduce user fees for cosmetic facility registration or product listing, so these submissions themselves do not carry an FDA charge (unlike the drug pathways). Your costs come from the compliance work behind them — assembling accurate product and ingredient data, safety substantiation and, where relevant, GMP evidence. Registrations renew on a recurring two-year cycle, so treat it as an ongoing obligation rather than a one-off task.
