MoCRA for European Cosmetics Brands: Why an RP and a PIF Aren't Enough
- Alok Naik, MS- Regulatory Affairs
- Aug 16
- 2 min read
If you sell cosmetics in the European Union, you already run a mature compliance system: a Responsible Person established in the EU, a Product Information File for every product, and CPNP notification.
It is tempting to assume a framework that thorough covers the United States too.
It does not. MoCRA runs in parallel, not downstream.
The Two Steps That Are Not Optional
If a facility manufactures or processes cosmetic products for U.S. distribution and sits outside the United States, two obligations attach to it.
Register the facility with FDA through Cosmetics Direct, FDA's Structured Product Labeling authoring tool. Renewed every two years.
Name a U.S. Agent in that registration. Section 607 of the Federal Food, Drug, and Cosmetic Act requires a foreign facility's registration to carry the contact for its United States agent.
Without the second, the submission is not complete.
Now note what the statute does not say. It does not require your U.S. Agent to be responsive, competent, or reachable.
That is a commercial risk you carry, not a standard FDA enforces up front. It becomes a legal problem later, when a notice goes unanswered — because information FDA gives your U.S. Agent counts as information given to you.
Product Listing Is a Separate Clock
Facility registration and product listing are two different duties on two different schedules.
Facility registration — renews every two years
Product listing — updated annually, per product, including ingredients
Brands that treat these as one filing tend to find the gap only when a listing has quietly gone stale.
The Mirror Problem: U.S. Brands, Foreign Manufacturers
The same rule catches U.S. brands from the other direction. A head office in New York does not make the obligation domestic.
If manufacturing happens abroad, that foreign facility must be registered and must have a U.S. Agent named in its registration.
Here the law adds a wrinkle worth knowing. FDA requires only a single registration per facility, and it may be filed either by the facility itself or by a responsible person whose products are made there.
That flexibility is where obligations go missing. The brand assumes the manufacturer filed. The manufacturer assumes the brand did. Neither did.
What to Check This Quarter
Confirm in writing which party filed the facility registration, and on what date, so the renewal has an owner.
Check that the U.S. Agent named in it is an entity that will actually answer.
Verify every marketed product is listed, and that the listing matches the current formula and label.
Make sure your label carries a U.S. contact for adverse event reports.
Confirm you have an intake process that can meet the 15 business day window for serious adverse events.
Axentra acts as U.S. Agent for foreign cosmetic facilities, handles FDA registration and listing, and reviews FDA correspondence before it reaches you.
The Market Access Bundle is $299 per facility, per year.
Email info@axentracompliance.com or call +1 505 358 4858.
This article is general information, not legal advice. Verify current requirements at fda.gov.
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