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What types of cosmetic certificates does FDA issue, and how do I obtain them?
FDA issues two types of certificates for cosmetics: General Product-Specific You will need to determine from the importing country which type of certificate will be acceptable. The certificates are described as follows: General 'CERTIFICATE': A General Certificate (the actual certificate will be titled only 'CERTIFICATE') does not list any specific products by name. It states that FDA has on file a letter 'regarding The Status Of Products Exported From The United States.' You only need to tell us how many General Certificates you require. You need not submit any other information. Attached to each General Certificate is a 'To Whom It May Concern' letter, which we supply, with your company's name and address. Product-Specific 'CERTIFICATE': A Product-Specific Certificate (the actual certificate will be titled only 'CERTIFICATE') states that FDA has on file a letter regarding specific product(s), listed by name in a Product List, which you supply, and which we will attach to the Product-Specific Certificate. Also attached to each certificate is a 'To Whom It May Concern' letter, which we supply, with your company's name and address. If you wish to obtain a Product-Specific Certificate, you should: Determine the number of products to be listed on each certificate. For example, if you need five certificates for five products, decide whether you want a single product listed with each certificate or all five products listed with each certificate. Type a Product List including all products that you want listed for each certificate, listing all products by their brand names, exactly as they appear on the cosmetic product labels. Do not submit labels. Include a Product List for each Product-Specific Certificate you request, since one list will be attached to each certificate. The Product List should be typed on an 8.5' X 11' sheet of paper. The format should include the words PRODUCT LIST centered at the top, with the name(s) of the cosmetic product(s) typed below at the left margin. If your product is a cosmetic, and you wish to request a certificate from FDA complete Form FDA 3613d (PDF), Office of Cosmetics and Colors 'Certificate' Export Application, and mail your completed form, along with your product list(s) if you are requesting Product-Specific Certificates, to: Certificate (Exports) Request Office of Cosmetics and Colors, HFS-125, CPK-2 Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740-3835 Additional questions concerning export certificates can be directed to the Office of Cosmetics and Colors at (301) 436-1130.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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