MoCRA borrowed a lot of vocabulary from European cosmetics regulation. Responsible Person. Product listing. Good Manufacturing Practices. Safety substantiation.
If you run compliance for an EU brand, each of those already means something specific to you. In the US framework, most mean something else — and assuming they translate is where American market entry quietly goes wrong.
1. “Responsible Person”
In the EU: a legal entity established in the Union, named in the CPNP notification, holding the Product Information File and carrying legal liability.
Under MoCRA: the manufacturer, packer or distributor whose name appears on the label. That is the whole definition.
There is no requirement to appoint a separate US-established RP entity the way the EU requires an EU-established one. But the label must carry a US address, US phone number or electronic contact information so consumers can reach the RP about adverse events.
The role travels with your label, not with a mandate letter — and its obligations (product listing, adverse event reporting, safety records, fragrance allergen disclosure, recalls) are yours whether or not you have anyone in the US.
2. “Product listing”
In the EU: CPNP notification. You notify, you may sell.
Under MoCRA: you list, and you may sell. Superficially the same, and there is no approval step in either case.
The differences are procedural. Listing goes through the FDA’s Cosmetics Direct portal, must be updated annually, and new products must be listed within 120 days of entering interstate commerce. A CPNP notification needs no annual refresh.
One genuine convenience: MoCRA permits flexible listings. Products with identical formulations, or differing only in colour, fragrance, flavour or fill size, can be grouped under one listing. The EU treats each as a separate notification.
3. “Facility”
In the EU: no analogue — there is no EU-level registration of cosmetic manufacturing sites.
Under MoCRA: any establishment manufacturing or processing cosmetic products distributed in the US must register with the FDA, domestic and foreign alike, renewing every two years.
Two details cost European brands time. Foreign facilities must appoint a US agent with a physical US address — PO boxes are not accepted — to handle registration and act as the FDA’s contact point. And the owner or operator needs an FEI number from the FDA before registering at all.
Establishments that only label, relabel, package, repackage, hold or distribute are excluded, as are salons, retailers, pharmacies and hotels.
4. “Safety substantiation”
In the EU: a Cosmetic Product Safety Report with a prescribed structure, prepared by a qualified safety assessor.
Under MoCRA: evidence sufficient to support a reasonable certainty that the product is safe, as judged by qualified experts. No prescribed format, test list or assessor qualification.
European teams read this as permissive. It is the opposite: the burden of designing the argument shifts to you, and the standard is only tested when the FDA asks. A well-built CPSR is a strong basis, but it must be maintained as records you can produce, not a document you once commissioned.
5. “GMP”
In the EU: ISO 22716, the harmonised standard.
Under MoCRA: FDA-issued Good Manufacturing Practice requirements developed under a mandate in the Act. ISO 22716 is a sound starting point and much overlaps, but the two are not automatically equivalent. Treat your certification as evidence, not a completed obligation, and track the FDA’s rulemaking.
6. “Cosmetic”
In the EU: Regulation 1223/2009 captures soap.
Under the FD&C Act: the statutory definition explicitly excludes soap.
That carve-out has stranded more than one European soap brand arriving to expect cosmetic rules. The broader classification trap is familiar — therapeutic claims move a product into drug or OTC territory — but the soap exclusion is specific to the US and easy to miss.
7. “Federal compliance”
In the EU: harmonised. Compliance is compliance in all member states.
In the US: federal law is the floor, not the ceiling. California Proposition 65 and a growing set of state ingredient restrictions apply on top of the FD&C Act and MoCRA. A product that satisfies the FDA can still be non-compliant in a given state — the difference EU brands underestimate most, because the EU spent decades removing exactly this fragmentation.
What actually needs doing
Colour additives require FDA approval before use, with narrow exceptions, and only for their approved uses. Talc, asbestos and PFAS are subject to ongoing rulemaking. Professional-use products need a statement restricting use to professionals, and fragrance allergens must be disclosed under rules the FDA is developing.
MoCRA also gave the FDA teeth it lacked before: facility inspections, access to safety records and fragrance formulations, mandatory recall authority and power to suspend a facility registration.
Consultancies covering USA cosmetics regulations typically provide US agent and RP support, classification and formula review, labelling review, product listings and facility registrations, and safety evaluation. For an EU brand the US agent piece is usually the trigger — it is the one obligation you cannot discharge from Europe.
One exemption worth checking: small businesses with average gross annual US sales below one million dollars over the previous three years are exempt from GMP, facility registration and product listing. It does not extend to products contacting the mucous membrane of the eye, injected products, products for internal use, or products altering appearance for more than 24 hours.
