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Exporting cosmetics and beauty products from the US

The US does not require an export certificate for cosmetics, but importing countries often ask for one. The FDA issues a certificate, titled "CERTIFICATE", for US-made products whose intended use is solely cosmetic, through the CAP module of eCATS. Some states and trade associations issue certificates too. Products made only for export follow section 801(e).

Updated · Each section links to the official source it comes from

US requirement for a certificate
None; the destination decides
FDA certificate
"CERTIFICATE", product-specific or general
Certificate of Free Sale for cosmetics
Not issued by the FDA
Not covered
Foreign-made cosmetics, raw or bulk materials, drugs
Authentication
Online verification, or a State Department apostille
Export-only products
FD&C Act 801(e), records kept 3 years

Before the goods leave

The questions to answer, in the order they usually come up.

  1. 1Is the product solely a cosmetic, or a drug under US law because of its claims? Read more
  2. 2Does the destination accept a general certificate, or need a product-specific one? Read more
  3. 3Would a state or trade association certificate be accepted instead? Read more
  4. 4Does the destination need an apostille or authentication? Read more
  5. 5Is the product made to the buyer's specification and not sold in the US? Read more
  6. 6Does the shipment need EEI, and who files it? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

The FDA cosmetic export certificate

What the FDA issues for cosmetics, for which products, and how.

  • The FDA does not require an export certificate and is not required by law to issue cosmetic certificates, though it provides them as resources permit.
  • Certificates are issued only for products whose intended use is solely cosmetic; products with drug claims, such as sun protection, acne or dandruff treatment, or hair growth, are drugs under US law.
  • The FDA does not issue certificates for cosmetics made outside the US, or for raw or bulk materials, and does not issue Certificates of Free Sale for cosmetics.
  • A product-specific certificate lists each product by brand and product name exactly as on the label; a general certificate lists none and is not always accepted.
  • Applications go through the Certificate Application Process (CAP) module of eCATS, on FDA Industry Systems, and may take several weeks.
  • A certificate does not mean the FDA approves the labels or finds the products in compliance, and the FDA does not change its wording or notarise it.

How we help: Compliant Always keeps the certificate and its product list with each product and lot, dated, and reads it against what the destination asks for. Ask about this

State and association certificates, apostilles and verification

Other certificates some foreign governments accept, and how a certificate is authenticated.

  • Some foreign governments accept certificates from a state or local health department, board of trade or trade association, and the FDA recommends these where they are acceptable.
  • The FDA names California, New Jersey and Texas as states offering cosmetic export certificates.
  • Anyone who receives an FDA cosmetic export certificate can verify it online through the FDA's verification portal.
  • The exporter can also request an apostille or authentication from the US Department of State, sending the original certificate with form DS-4194.

How we help: Compliant Always keeps state, association and FDA certificates side by side with the product, and shows which ones a destination has not yet been matched to. Ask about this

Cosmetics made only for export

Section 801(e)(1) of the FD&C Act, where a product meets the destination's rules but not the FD&C Act or the FPLA.

  • A cosmetic intended for export is not considered adulterated or misbranded if it meets the foreign purchaser's specifications, does not conflict with the destination's laws, is labelled on the outside of the shipping package as intended for export, and is not sold in domestic commerce.
  • Cosmetics sold or offered for sale in the US must meet the FD&C Act, the Fair Packaging and Labeling Act and related regulations.
  • The exporter keeps records showing each condition, such as a letter from the foreign authority or a notarised company certification, for 3 years after exportation (21 CFR 1.101(b)).

How we help: Compliant Always keeps the buyer's specification, the destination evidence and the export marking with each lot, dated, ready if the FDA asks. Ask about this

Export declaration: EEI in the AES

Electronic Export Information filed in the Automated Export System, the export component of ACE, before the goods leave.

  • The EEI is filed through the AES by the US principal party in interest (USPPI), its authorised agent, or the authorised US agent of the foreign principal party in interest, for exports of physical goods, including orders received over the internet (15 CFR 30.2).
  • No EEI is needed where the value under one Schedule B or HTSUSA number, from one USPPI to one consignee on one conveyance, is $2,500 or less, unless a licence is required (15 CFR 30.37(a)).
  • Shipments to Canada are exempt, except goods stored in Canada for a third country or moving through Canada to one (15 CFR 30.36).
  • Filed before departure: 24 hours before loading for vessel cargo, 2 hours before departure for air cargo, 1 hour before a truck reaches the border (15 CFR 30.4).
  • Each line carries a 10-digit Schedule B or HTSUSA number and, where it applies, the ECCN or EAR99 (15 CFR 30.6).
  • Parties to the export keep its documents for five years from the date of export (15 CFR 30.10).

How we help: Compliant Always keeps the invoices, classifications and certificates behind each declaration with the shipment and lot, dated, and answers importers' questions from that record. Ask about this

Export controls: EAR99 and the general prohibitions

Whether the Export Administration Regulations call for a licence, which for most consumer goods turns on the destination and the buyer.

  • Items in the United States and US-origin items wherever located are subject to the EAR (15 CFR 734.3).
  • Items subject to the EAR but not listed on the Commerce Control List are designated EAR99 (15 CFR 734.3(c)).
  • BIS: EAR99 items do not need a licence in most situations, but may if destined for a prohibited or restricted end user, end use or destination of concern.
  • Denial orders, prohibited end uses and end users, and embargoed destinations such as Cuba, Iran, North Korea and Syria apply to EAR99 items too (15 CFR 732.3).

How we help: Compliant Always keeps each product's export classification with its record, dated, and shows where one is missing before a shipment. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ExporterKnowing the destination's cosmetic rules, applying for certificates and, as USPPI, the EEI.Certificates and declarations kept with each shipment, with gaps shown before it leaves.
Brand or manufacturerThe product names and labels a product-specific certificate lists, and the claims that decide cosmetic or drug.Labels and product lists kept current with each product.
Freight forwarder or customs brokerFiling EEI as the authorised agent.The commercial documents behind the filing, in one record.
Certifying authorityThe FDA's Office of Cosmetics and Colors, a state health department or a trade association.Each certificate read against what the destination asks for.

Where are the goods going?

Most of what cosmetics and beauty products have to meet is set where they are sold. Each guide sets out the rules on arrival, with the official source for each.

Questions businesses ask

Do I need an FDA certificate to export cosmetics from the US?
Not under US law. The FDA does not require an export certificate, but foreign governments or customers often ask for one as part of importing a product. Knowing the destination's requirements is the exporter's responsibility.
Does the FDA issue a Certificate of Free Sale for cosmetics?
No. All FDA cosmetic export certificates are titled "CERTIFICATE". The FDA does not issue Certificates of Free Sale or other types of cosmetic certificate.
Can the FDA certify cosmetics made outside the US?
No. The FDA does not issue cosmetic export certificates for products manufactured outside the US, or for raw or bulk materials.
Can I get a cosmetic export certificate for a sunscreen or acne product?
Not a cosmetic certificate. Products with claims such as sun protection or acne treatment are drugs under US law, and the FDA issues cosmetic certificates only for products whose intended use is solely cosmetic.
What is the difference between a product-specific and a general certificate?
A product-specific certificate lists each product by brand and product name exactly as on the label. A general certificate lists no products and is not always accepted by importing countries.
How long does an FDA cosmetic export certificate take?
It may take several weeks, depending on the FDA's workload and whether the product appears not to be a cosmetic. The FDA recommends applying online through CAP.
Can a state issue a cosmetic export certificate?
Yes. The FDA names California, New Jersey and Texas, and says some governments accept certificates from state or local health departments, boards of trade or trade associations.
How do I get an apostille for an FDA cosmetic certificate?
Send the original certificate printed from CAP, form DS-4194 and payment to the US Department of State's Office of Authentications.
Can I export a cosmetic that does not meet US rules?
Under FD&C Act section 801(e)(1), if it meets the buyer's specifications, does not conflict with the destination's laws, is marked for export on the shipping package and is not sold in the US. Records are kept for 3 years.
Do I need to file EEI to export cosmetics?
Yes, through the AES, unless an exemption applies, such as $2,500 or less under one Schedule B number to one consignee, or most shipments to Canada.
How does Compliant Always help with exporting from the US?
Our team reads the rules for the routes you ship. Compliant Always shows which export documents apply to your product, keeps them with the shipment beside what the destination asks for, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in the US and what your paperwork needs to show.

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