Cosmetic Export Certificates
Firms exporting products from the United States are often asked by foreign governments or customers to supply a "certificate" as a required part of the process to import a product into their country. Please note:
FDA does not require that you obtain an export certificate.
FDA is not required by law to issue certificates for cosmetics (although the agency intends to continue to provide this service as resources permit).
FDA does not issue certificates for cosmetics manufactured outside the United States, or for raw or bulk materials.
Follow all applicable U.S. laws and regulations
Know the cosmetics requirements of the countries to which you export
To avoid unnecessary delays, please read the information below before you request a cosmetic export certificate.
How do I obtain a cosmetic export certificate?
FDA has a secure Web-based export certificate application system called Certificate Application Process (CAP). To access CAP, go to FDA Industry Systems and follow the steps to create an account. You will then be able to request certificates in CAP.
Benefits of CAP for cosmetics include--
Online submission of applications
Online receipt, download, and printing of certificates
Status updates via email and online tracking
Ability to copy, edit, and resubmit applications
If you are unable to apply online, our paper Form FDA 3613d (PDF 709 KB) is still available. If you use the paper form, you must mail the original to FDA. Copies are not accepted. You will receive your certificates by email even if you use the paper form to request them.
Is my product really a cosmetic under the law?
FDA can only issue cosmetic export certificates for products whose intended use is solely cosmetic. Products that are intended to cleanse the body or promote attractiveness are cosmetics, while products that are intended to affect the structure or function of the body, or to have a therapeutic effect such as treating or preventing disease are drugs under U.S. law. Products marketed as "soap" may be cosmetics or drugs regulated by FDA, or they may be consumer products regulated by the Consumer Product Safety Commission, depending upon their composition and intended use.
Intended use may be established in a number of ways, including--
Claims made on the product label, in collateral labeling, in Internet information, or in other promotional materials such as advertising;
Consumer perception; and
Ingredients that have a well-known therapeutic use.
Many personal care products are actually drugs under U.S. law, such as products with claims of--
Sun protection, including use of a sun protection factor (SPF)
Prevention and treatment of dandruff and acne
Hair restoration and growth
Skin bleaching and lightening
Skin and lip balm
Immune and circulatory system improvement
Skin lesion healing
For more information on whether your product is a cosmetic or a drug, or whether your "soap" is regulated by FDA or the Consumer Product Safety Commission, please refer to "Cosmetics Q&A: Personal Care Products" and "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)."
For information on how to request export certificates for other FDA-regulated products, see--
Medical Devices: Exporting Medical Devices FAQs
Foods (including dietary supplements): Export Certificates
What types of export certificates does FDA issue for cosmetics?
The title of all FDA-issued cosmetic export certificates is “CERTIFICATE.” FDA does not issue Certificates of Free Sale for cosmetics or other types of cosmetic certificates. We cannot change the wording of our certificates, and we do not notarize them.
When applying for a cosmetic export certificate, you will be asked whether you would like a certificate that is--
Product-Specific: This type includes a list of all certified products. You must submit this “Product List,” with all products listed by their brand and product names, exactly as they appear on the cosmetic product labels.
General: This type does not include a list of products. We suggest that you determine whether this type of certificate meets the requirements of your importing country before requesting one, because it is not always accepted.
How much does a cosmetic certificate cost?
How long will it take to process my cosmetic certificate request?
Requests for cosmetic export certificates may take several weeks to process. The following factors may have a bearing on processing time:
For paper applications sent via mail--It takes time for them to be delivered to our review staff who then must manually record your request into the Certificate Application Process (CAP) system. For this reason, we recommend that you apply online.
There may be a delay if your product appears not to be a cosmetic. FDA can only issue cosmetic export certificates for products whose intended use is solely cosmetic. If it is determined that a product is not a cosmetic, your request will be returned to you and you will have to submit a new request to the proper office.
FDA’s regulatory workload when we receive your request may affect response time. FDA is not required to issue export certificates for cosmetics. Public health activities are our top priority and take precedence over processing certificates.
Are there other sources of cosmetic certificates, besides FDA?
Some foreign governments may accept certificates issued by a state or local health department, board of trade, or trade association. Because FDA's resources are limited, we recommend that firms pursue alternative sources such as these for export certificates whenever possible, provided they are acceptable to the country requiring a certificate.
The states listed below offer cosmetic export certificates. This list may not be all inclusive. If your state is not listed, you may wish to check with state authorities to determine whether your state does provide certificates for cosmetics.
California Department of Public Health
Food and Drug Branch Export Document Program
Telephone: (916) 650-6500
New Jersey Department of Health
Food and Drug Safety Program
Telephone: (609) 826-4935
Fax: (609) 826-4490
Bureau of Food and Drug Safety
Texas Department of State Health Services
Telephone: (512) 834-6626, ext. 2405
Some governments may accept a certificate issued by a U.S. trade association, such as the Personal Care Products Council, the Independent Cosmetic Manufacturers and Distributors, and the World Trade Center Denver.
Cosmetic requirements in other countries are different from ours, and there may be situations when a product for export does not comply with the requirements of the Federal Food, Drug, &Cosmetic Act (FD&C Act) or Fair Packaging and Labeling Act (FPLA) for cosmetics marketed domestically. A product intended for export will not be considered adulterated or misbranded if it--
meets the specifications of the foreign purchaser,
is not in conflict with the laws of the country to which it is intended for export,
is labeled on the outside of the shipping package that it is intended for export, and
is not sold or offered for sale in domestic commerce. (FD&C Act, Section 801(e); U.S. Code, Title 21, sec. 381(e))
However, cosmetic products sold or offered for sale in domestic commerce must comply with all applicable provisions of the FD&C Act, the FPLA, and any other related laws, as well as the regulations established under authority of these laws.
The issuance of a certificate does not suggest or imply that FDA approves or sanctions the labels and labeling of the firm's products or that the firm's products are in compliance with the requirements of the FD&C Act, the FPLA, or related regulations. The issuance of a certificate does not preclude FDA from taking regulatory action against such products in the future, if such action is warranted. Further, a certificate does not constitute an admission, or agreement, or determination by FDA that a product is a cosmetic as defined in section 201(i) of the FD&C Act.
How do I learn other countries' requirements?
If you are an exporter, it is your responsibility to ensure that your products comply with regulations in the destination country. Significant differences exist among different countries. FDA cannot provide information on regulations in other countries. Embassies may be of assistance, or you may contact regulatory agencies in those countries directly for information.
How do I learn about other U.S. government requirements for exports?
You may need to work with other government agencies before exporting your products due to, for example, possible economic and trade sanctions, or hazardous material shipment concerns. Please refer to "Other Government Agencies You May Need to Know About" for a list of other government agencies and related links that may affect your domestic or export business.
What if I still have questions?
If you still have questions concerning cosmetic export certificates, please direct them to Jon Hicks of FDA's Office of Cosmetics and Colors at CAP-OCAC-CFSAN@fda.hhs.gov or (240) 402-1375.
For further information, including export certificates for other products regulated by FDA, see Guidance for Industry: Export Certificates.