MoCRA and CPSR for Small Cosmetics Brands¶
A small cosmetics brand selling in the US and the EU needs two parallel obligations: FDA MoCRA facility registration and product listing for the US, and a Cosmetic Product Safety Report plus a Responsible Person for the EU. Both start with the same product information.
The US side: MoCRA¶
- Facility registration: the manufacturer registers with the FDA, refreshed every two years
- Product listing: each product listed with its ingredients, renewed annually
- Adverse event records: serious events reported within 15 business days
- Responsible Person: a US entity named on the label
The EU side: CPSR¶
- Responsible Person: an EU based entity, named on the label
- Product Information File: formula, method of manufacture, claims substantiation
- CPSR: a safety assessment signed by a qualified safety assessor
- CPNP notification before first sale
One dataset, two markets¶
The formula, ingredient concentrations, and packaging details are the same in both markets. Structure the data once: ingredient lists with INCI names, concentration bands, and supplier documents attached. The US listing and the EU notification then become two views of the same record instead of two separate projects.
Frequently Asked Questions¶
Can a small brand act as its own EU Responsible Person?
Yes, if the brand has an EU address. Otherwise you appoint a third party, which adds cost, so factor it into pricing before launch.
Do I need a new CPSR for every shade?
No. One CPSR can cover a shade range when the formula differences are limited to approved colourants and the assessor documents it.
What is the fastest way to get both markets ready?
Prepare the product information file first. It feeds the FDA listing, the CPNP notification, and the CPSR assessment, so every other step gets shorter.
Structure Both Markets Once
Build your product and ingredient records once and publish the US and EU documents from the same data. Your first asset is free.
Global Digital Trust & Compliance
Sustalium is the digital-first platform for managing complex business certificates and sustainability declarations across global supply chains.
- Digital Product Passport (DPP)
- Carbon & Water Footprint
- Circularity & Reuse (ISO 14021)
- De-Forestation Free
- FSMA 204 (FDA Traceability)
- REACH & RoHS Compliance
- PFAS-Free & VOC Declarations
- Prop 65 & TSCA Title VI
- ISO 26000 Responsibility
- Modern Slavery Statements
- UFLPA Forced Labor Traceability
- Ethical Labor Declarations
- Swiss Made & Origin Claims
- GDPR & AI Ethics (EU AI Act)
- CE Marking & UKCA Conformity
- Bill S-211 (Canada) Reporting
Have questions about a specific standard?
Contact our compliance team at compliance@sustalium.com