United States — MoCRA in plain English
The Modernization of Cosmetics Regulation Act (MoCRA), enforced from 2024 onward, requires facility registration, product listings, adverse-event recordkeeping and substantiation of safety for every cosmetic sold in the US. Most reputable manufacturers handle facility registration; product listings and safety substantiation are typically the brand owner's responsibility.
European Union — EC 1223/2009 essentials
To sell in the EU you need a designated Responsible Person inside the EU, a complete Product Information File (PIF), a Cosmetic Product Safety Report (CPSR) by a qualified assessor, and a CPNP notification before the product ships. Plan 6 to 10 weeks for full EU readiness once your formula is locked.
United Kingdom — SCPN after Brexit
The UK now requires a separate UK Responsible Person and notification through the OPSS Submit Cosmetic Product Notifications (SCPN) portal. Documentation overlaps heavily with EU PIF, but the notifications are not transferable.
Label requirements that trip up new brands
Common label failures: missing batch code, INCI list out of order, ingredients below 1% not grouped correctly, country of origin omitted, net contents in the wrong unit or font size. Have your manufacturer's regulatory team review label artwork before printing — every time.
Frequently asked
- Do I need FDA approval to sell skincare in the US?
- No. Standard cosmetics are not pre-approved by the FDA. You do need to comply with MoCRA — facility registration, product listings, safety substantiation and adverse-event records. OTC drug products like sunscreen and acne treatments have separate, stricter requirements.
- Can my US manufacturer act as my EU Responsible Person?
- Only if they have a legal entity inside the EU. Most US-only manufacturers will refer you to a third-party Responsible Person service, which typically costs €1,500 to €4,000 per year per brand.