Glossary—free sale certificate

GISTnet Glossary—free sale certificate

This is a document issued by a government agency, official chamber of commerce or trade association in the country of export confirming that a specified product meets applicable government safety, labeling and point-of-sale packaging requirements in the country of export, and so is government approved and/or otherwise unrestricted for sale within the country of export.

Many countries require a free sale certificate as a condition of importation for products that potentially pose consumer health and safety concerns (e.g., pharmaceuticals, medical devices, cosmetics, processed food including beverages and ingredients, products that emit radiation).

Certain nations require that a free sale certificate be issued by a national government agency for particular product categories, whereas otherwise a certificate issued by a lower-level government agency, official chamber of commerce or trade association may be acceptable.

An exporter obtains a free sale certificate by application to the issuing agency or organization. Such application typically requires payment of a fee and specified supporting documentation. For example, chambers of commerce and trade associations will typically require an affidavit from the manufacturer of the product that it is in fact sold without restriction in the domestic market, plus some form of proof in the form of certified invoices for sale to domestic customers. A certificate may list more than one product (by product name, model number, stock number, etc.), in which case proof of sale for each product must be provided. Industry-specific trade associations will typically issue free sale certificates only for member companies.

Many countries will accept copies of previously-issued certificates for multiple shipments of covered products between the same exporter and importer, and sometimes for all exports from the particular shipper to any importer. If copies of a previously issued certificate are used, they should be additionally certified and hand-signed each time they are used by the exporter.

Sufficient time prior to intended export date must be allowed to obtain the certificate; this may range from several days to weeks, especially for a certificate issued by a government agency.

There is considerable variation by destination country and type of product as to acceptability of a free sale certificate issued by other than the national government in the country of export. For a type of product that may require a free sale certificate, an exporter should check with its customer or destination country trade consultant specializing in the particular product well in advance of an initial export to a new customer if a free sale certificate (or equivalent document under another title) will be required for import, and if so whether a certificate issued by other than the national government agency in the export country responsible for regulating the product may be acceptable.

(U.S.) In the U.S., free sale certificates, or the functional equivalent under another title, are issued by both USG agencies that regulate particular products as well as by some trade associations and chambers of commerce.

The USG issues a variety of export certificates for a variety of exported products attesting to health, safety and/or approval for sale of such products within the U.S. These certificates, which may have a title other than "free sale certificate," are issued by the U.S. agency that regulates the particular product being certified.

The FDA will issue certificates on:

Pharmaceutical and biologic products
Medical devices and certain radiation-emitting products
Cosmetics
Veterinary products
Processed foods and food additives including dietary supplements
Fishery and aquaculture products (seafood)

For overview information, including application procedures and limitations on issuance of certificates, refer to FDA Export Certificates. For FDA contact information for particular products, refer to Export Certificate Contacts.

For an initial export of an FDA-regulated product for which your foreign customer has requested a free sale certificate and/or for which the destination country import regulations require one, contact the FDA well in advance of export to verify that the FDA will issue the type of certificate requested or the equivalent under another title, the application processing time and fee.

Though not referred to as free sale certificates, the USDA also issues export certificates in the form of health certificates (for live animals and unprocessed or minimally processed animal products) or phytosanitary certificates for live plants, seeds, produce, unprocessed or minimally processed plant products, and a few specified animal products. Refer to the USDA website, About Food Export Certificates for a summary of export certificates by type of product and Food Export Certificate Project for an overview and USDA and FDA contact parties, useful for clarification as to food which falls under FDA vs. USDA regulation.
Note: The issuance of health and phytosanitary certificates has been widely delegated to state and/or county animal and plant health/inspection services. Some destination countries accept such state and local certificates, whereas others require a certificate issued by the USDA; in such cases, the USDA will typically issue its own certificate in exchange for the state or local certificate.

Free sale certificates are also issued by:

State agencies for certain products produced within its state (e.g., agricultural and food products). For example, the Wisconsin Department of Agriculture Trade and Consumer Protection (DATCP) will issue "Certificates of Free Sale," "Purity Certificates" or "Certificates of Sanitation" for producers that it directly inspects.
Industry associations – For example, the American Cosmetics Manufacturing Association and Personal Care Products Council with respect to cosmetics and toiletries for its member companies
Chambers of commerce in the U.S. provide free sale certificates on most products, provided the applicant provides evidence that the product is regularly sold in commerce within the U.S. As examples, see Los Angeles Area Chamber of Commerce, Chicagoland Chamber of Commerce, World Trade Center Denver.

For products whose safety is regulated by agencies other than the FDA or USDA, if the regulating agency requires product testing and/or other approval prior to sale (e.g., type approval by the FCC in the case of a device emitting radio frequency radiation), the type approval certificate issued to the product manufacturer may be required in lieu of a free sale certificate.

The acceptability of a free sale certificate issued by a state agency, industry association or chamber of commerce varies significantly by destination country and type of product. Before applying for a free sale certificate, consult with the importer, importer's customs broker or other knowledgeable expert as to whether a USG-issued certificate is required vs. one issued by a state agency, trade association and/or chamber of commerce.