By Vincent Cruz

France is the world’s leading cosmetics exporter, and French brands — from prestige houses to pharmacy favorites — carry instant credibility with American buyers. What they do not carry is regulatory credit. The EU cosmetics file is the most elaborate in the world, and FDA accepts none of it in place of U.S. filings. Brands that assume their European paperwork is a global passport are the ones that get shipments held and launches delayed.

This guide is for the French brand owner planning a U.S. launch. For the full compliance picture, start with the MoCRA Compliance Guide for Cosmetic Brands.

The core rule: your EU file does not transfer

Everything in this guide follows from one fact: FDA does not recognize EU compliance as a substitute for U.S. compliance. Specifically:

Your EU Responsible Person has no standing with FDA. MoCRA has its own “responsible person” concept (the manufacturer, packer, or distributor whose name appears on the label), a different legal role under a different law.
Your CPSR and Product Information File (PIF) are not U.S. filings. The Cosmetic Product Safety Report is thorough and can support your records, but FDA does not accept it in place of anything. MoCRA’s safety substantiation is a separate U.S. requirement, explained below.
Your CPNP notification means nothing to FDA. The EU notifies products to Brussels; the U.S. lists them with FDA in a different system with different data.
Your EU GMP certification (ISO 22716) and French manufacturing authorizations are evidence of good practice, but none of them satisfies a U.S. filing requirement.

Plan your U.S. launch as a fresh compliance project, not an export of your EU dossier.

Step 1: Register your facility with FDA

If your products are manufactured or processed in France (or anywhere outside the U.S.) for sale in America, the facility must register with FDA. Key points for French brands:

You need an FEI number first. The FDA Establishment Identifier is required before registration can be filed. Request it from FDA by email; processing typically takes 7 to 10 business days. Run the free FEI check to see whether your facility already has one.
Registration is filed through Cosmetics Direct, FDA’s online portal, using Form FDA 5066. The step-by-step process is covered in Cosmetics Direct: How to Register Your Facility.
Registration renews every two years, based on your facility’s initial registration date, with automated reminders from FDA. See MoCRA Biennial Renewal Explained.
Using a French contract manufacturer (façonnier)? The facility that manufactures the product is the one that registers. If a contract lab in France makes your products, that lab’s facility registers (and needs its own U.S. agent). See Private Label Cosmetics: Who Registers Under MoCRA.

A common French-brand mistake: assuming your American subsidiary’s or distributor’s registration covers your French factory. It does not. The manufacturing facility registers; a distributor cannot register on the manufacturer’s behalf.

Step 2: Name a U.S. agent

Every foreign facility registering with FDA must designate a U.S. agent: a person or business physically present in the United States who serves as FDA’s official contact for the facility. This is not optional, and your EU Responsible Person, your Paris headquarters, and your export department are all disqualified by geography alone.

The agent receives FDA correspondence, relays it to you, and is the contact FDA reaches out to with questions about your facility. The service is standardized — our own pricing is a flat $450 one-time setup plus $34.99 per month per facility, with the full cost picture in MoCRA U.S. Agent Cost. For how to evaluate providers, see How to Choose a MoCRA U.S. Agent and Who Can Be a MoCRA U.S. Agent.

Step 3: List your products

Each cosmetic product sold in the U.S. must be listed with FDA through Cosmetics Direct (Form FDA 5067), filed by the responsible person. Listings include product and ingredient information and must be updated annually.

Note the EU difference: CPNP is a pre-market notification to European authorities; the U.S. listing is a filing with FDA under a different format and different legal consequences. Do both; neither substitutes for the other. See Facility Registration vs Product Listing Explained.

Step 4: Fix your labels for the U.S. market

EU labels are close to U.S. labels in spirit and wrong in almost every detail. The differences that matter most:

Ingredient names. Several everyday names differ. U.S. labels say “Water,” not “Aqua,” and “Fragrance,” not “Parfum.” Color additives are declared by their U.S. names, not CI numbers. Your INCI list needs a conversion pass, not a copy-paste.

Ingredient order. The U.S. requires ingredients in descending order of predominance, with its own rules for low-concentration ingredients and color additives. The EU’s ordering allowances, including the flexibility for ingredients at 1% or less, do not carry over.

Fragrance allergens. EU law requires individual fragrance allergens — limonene, linalool, geraniol, and a list expanded in 2023 — to be named on the label. U.S. law does not currently require individual allergen disclosure; FDA’s allergen rule is still in development. An EU allergen declaration is formatted for the wrong market and needs rebuilding to U.S. conventions.

Net quantity. U.S. consumer commodities must state net quantity in both U.S. customary and metric units, in a specific location on the principal display panel. Metric-only French labels need updating.

Domestic contact for adverse events. MoCRA requires every label to carry domestic contact information — a U.S. address, U.S. phone number, or electronic contact — through which consumers can report adverse events. Your French address does not serve this purpose.

Claims review. This is where French pharmacy brands get hurt. French dermocosmetics marketing is built on clinical language: percentages of wrinkle reduction, cell regeneration, anti-inflammatory action. In the U.S., claims that a product changes the structure or function of the skin are drug claims — the single most common France-to-US failure point. See Is Your Product a Cosmetic or a Drug? and MoCRA Labeling Changes.

Safety substantiation: the CPSR is not the U.S. requirement

MoCRA requires the responsible person to maintain safety substantiation: records demonstrating adequate substantiation of safety for each product, available to FDA on request. Your CPSR is genuinely useful source material — a well-built PIF covers much of the underlying evidence. But the U.S. obligation is separate: it attaches to the MoCRA responsible person (not your EU Responsible Person), follows U.S. expectations rather than the EU assessment format, and no European document discharges it. See MoCRA Safety Substantiation.

The pitfalls that catch French brands specifically

Assuming the EU file is a global passport. The most common and most expensive mistake. Separate filings, separate labels, separate agent, separate substantiation records.
Pharmacy anti-aging claims. The claims that sell French pharmacy brands at home — measured wrinkle reduction, regeneration, repair at the cellular level — are drug claims in the U.S. Rebuild the claims, or you are marketing an unapproved drug.
SPF and suncare. Sunscreen is a cosmetic in the EU and a drug in the U.S. French suncare brands face an entirely different FDA pathway: different registration, Drug Facts labeling, drug manufacturing standards.
Ingredient legality mismatches. EU and U.S. restricted lists do not match in either direction, and U.S. color additive rules are their own system — every color must be FDA-permitted for the intended use, and some require FDA batch certification.
Relying on the distributor. Your U.S. distributor may offer to “handle compliance.” They cannot register your French facility or serve as its U.S. agent unless they formally take on that role and meet FDA’s requirements.
Small-business exemption confusion. The U.S. small-business exemption (Section 612 of the FD&C Act, 21 U.S.C. section 364h) is based on U.S. sales, not French turnover, and never exempts labeling, safety substantiation, or adverse event reporting. Check the exemption worksheet rather than assuming.
Forgetting the ongoing duties. Registration is not a one-time event: biennial renewal, annual listing updates, serious adverse event reporting to FDA within 15 business days, and adverse event records kept for six years. See MoCRA Adverse Event Reporting.

A note for brands already selling in the UK

If you already adapted your line for the British market, you have a head start on the claims and labeling mindset — but not on the filings. The U.S. sequence is its own; the closest comparison is our guide for UK brands.

A realistic France-to-US launch sequence

Classify every product as cosmetic or drug for the U.S. market (re-do claims and ingredients, not just labels).
Confirm whether you qualify for the small-business exemption; if not, proceed with full compliance.
Request your facility’s FEI number (7 to 10 business days).
Choose and appoint your U.S. agent.
File facility registration via Cosmetics Direct.
File product listings, and assemble U.S. safety substantiation records from your PIF.
Finalize U.S.-compliant labels before the first shipment.
Set up adverse event intake and record-keeping from day one.

For realistic timing on each step, see How Long Does MoCRA Facility Registration Take?.

FAQ

Does my CPSR count as safety substantiation in the U.S.?
Not by itself. MoCRA requires the responsible person to maintain adequate safety substantiation under U.S. law. Your CPSR and PIF are strong source material for building those records, but the obligation is American, it belongs to the MoCRA responsible person, and FDA does not accept the European file in place of it.

Does my CPNP notification count as a U.S. product listing?
No. The two systems are completely separate. You must list products with FDA through Cosmetics Direct regardless of CPNP status.

Can my EU Responsible Person be my U.S. agent?
No. The U.S. agent must be physically present in the United States (residing there or maintaining a U.S. place of business). An EU-based person or company does not qualify.

Do I have to redo my labels if they are already in English?
Yes, in practice. English-language EU labels still use EU ingredient names (“Aqua,” “Parfum,” CI numbers), EU allergen declarations, EU ordering rules, and metric-only quantities. U.S. labels need U.S. names and order, dual-unit net quantity, and a domestic contact for adverse event reports.

My creams claim clinically proven wrinkle reduction. Is that a problem?
Yes. In the U.S., claims that a product reduces wrinkles by changing the skin’s structure or function are drug claims, however well-tested. Appearance-based claims (“reduces the appearance of wrinkles”) are cosmetic claims. French pharmacy marketing routinely crosses this line, so a claims review comes first in any U.S. launch.

How long does the whole process take for a French brand?
The FEI request alone takes 7 to 10 business days; registration details, agent appointment, substantiation records, and labels add more. Plan for several weeks minimum from a standing start; see How Long Does MoCRA Facility Registration Take?.

Next step: French brand planning a U.S. launch? Contact us for a straight assessment of what your products need, or run the free FEI check to confirm whether your facility already has an FDA Establishment Identifier.

This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA.