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Export Certificate Applications for Food and Cosmetic Products Under Review

Friday, January 09, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting comments through March 10 on the information collection provisions associated with export certificate applications for FDA-regulated food and cosmetic products.

Some foreign countries require manufacturers of FDA-regulated products to provide an export certificate for the products they wish to export to that country. The FDA’s Center for Food Safety and Applied Nutrition issues such certificates for food, food additives, seafood, dietary supplements and cosmetics. Interested persons may request a certificate by using the electronic CFSAN certificate application process, which is part of the FDA Unified Registration and Listing System, or by submitting paper forms FDA 3613d for cosmetic products or FDA 3613e for food products.

The following information is requested on Form FDA 3613d and the CFSAN certificate application process: the name of and contact information for the requester and exporting company (if different from requester); a designation of the type of certificate requested (general or product-specific); if product-specific, a list of the exact brand names of the products; the contact person, company name and address where the requested certificate should be sent; and the name and account number (if applicable) of the requester’s preferred carrier for delivery of the certificate. The requester’s signature, the name and title of the person signing the form, and the date signed are also required.

The following information is requested on Form FDA 3613e and the CFSAN certificate application process: the name of and contact information for the manufacturer and exporting company (if different from the manufacturer), as well as the state license or registration number for each; a description of the shipment including the product, common name and manufacturer and a description or additional comments; the name of the country to which the requester intends to ship the product; the contact person, firm name and address where the requested certificate should be sent; and the name and account number (if applicable) of the requester’s preferred carrier for delivery of the certificate. The requestor must submit an original or copy of the applicable product label or labels. The submitter’s signature, the name and title of the person signing the form, and the date signed are required as well.

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