INTERNATIONAL TRADE LAW
How to Export Cosmetics: FDA and EU Rules
To export cosmetics, you satisfy two layers of rules: the U.S. requirements that apply where you manufacture, and the destination country’s requirements that apply where you sell. A product that is perfectly legal to sell in the United States can be blocked at an EU border for a labeling or notification gap. The exporter’s job is to clear both layers before the goods ship — not to discover the second one when a shipment is detained.
Cosmetics are lightly pre-regulated in the U.S. compared with drugs, but “lightly” is not “not at all,” and the gap between U.S. and foreign rules is where exporters get caught.
The U.S. Layer: MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to U.S. cosmetics law in decades, and it reaches manufacturers who export. Its core obligations:
- Facility registration. Manufacturers and processors must register each facility with the FDA and renew that registration every two years.
- Product listing. The “responsible person” must list each marketed cosmetic product with the FDA, including its ingredients, and update the listing annually.
- Safety substantiation and adverse-event reporting round out the regime.
The FDA used enforcement discretion through July 1, 2024, after which it expected registration and listing to be in place; submissions go through the agency’s Cosmetics Direct portal. Cosmetics still generally do not need FDA pre-market approval (color additives are the main exception), but MoCRA’s registration and listing duties now sit underneath every U.S. cosmetics business, exporters included.
The Destination Layer: Selling Into the EU
The European Union regulates cosmetics far more tightly than the U.S., under Regulation (EC) No 1223/2009. Three requirements drive most export planning:
| Requirement | What it means for a U.S. exporter |
|---|---|
| Responsible Person (RP) | A person or entity established in the EU must take legal responsibility for the product. A U.S. company needs an EU-based RP — often the importer or a designated agent. |
| CPNP notification | Before the product is placed on the market, the RP notifies it through the Cosmetic Product Notification Portal. |
| Product Information File (PIF) | The RP maintains a dossier — including a cosmetic product safety report — available to authorities. |
The EU also bans animal-tested cosmetics and ingredients, restricts specific substances, and imposes its own labeling rules (ingredient names in INCI nomenclature, function, RP address, batch code). Meeting U.S. labeling does not satisfy EU labeling.
The Export Paperwork
Mechanically, exporting cosmetics follows the standard U.S. export path. Classify the product for export reporting with a Schedule B number, screen your buyer and distributor against the restricted-party lists, and file Electronic Export Information when the shipment crosses the $2,500-per-code threshold. Foreign buyers — particularly in the EU — frequently ask for a Certificate of Free Sale, a document confirming the product is legally sold in the U.S.; FDA and some state and trade bodies can issue these. If your target market is Europe specifically, read our guide to exporting to Europe alongside this one.
Frequently Asked Questions
Does the FDA approve cosmetics before export?
No. Most cosmetics do not require FDA pre-market approval. But under MoCRA, manufacturers must register their facilities and list their products with the FDA, and color additives remain subject to approval.
Do I need an EU Responsible Person to sell cosmetics in Europe?
Yes. EU Regulation 1223/2009 requires a Responsible Person established in the EU for every cosmetic placed on the market. A U.S. exporter usually designates the importer or an agent to fill that role.
What is a Certificate of Free Sale?
A document confirming a product is legally marketed in the U.S. Many importing countries request it before allowing cosmetics to enter; the FDA and certain other bodies can issue one.
Is U.S. labeling enough for export?
No. The EU and many other markets have their own labeling, ingredient, and notification rules. Plan for destination-specific labeling, not just U.S. compliance.
Cosmetics exporters answer to two regulators at once. Reidel Law Firm helps U.S. exporters map home and destination requirements and clear the export paperwork on flat-fee terms. Get an export compliance memo.
