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Form Approved: OMB No. 0910-0498; Expiration Date: 3/31/09

Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition 1. Requester Information
Company name Contact person name Contact phone Contact fax Contact email

OFFICE OF COSMETICS AND COLORS "CERTIFICATE" (EXPORTS) APPLICATION
Address

Date

City State Country ZIP/postal code

2. Exporting Company Information (the name and address to appear on the certificate)
Company name Contact person name Contact phone Contact fax Contact email City State Country ZIP/postal code Address

3. Type of "Certificate" Requested GENERAL Quantity: (Note: no specific products will be listed.)

PRODUCT SPECIFIC Quantity: You must type a "PRODUCT LIST" for each certificate requested. This Product List will be attached to your export Certificate. For each product include the exact brand name as it appears on the label. (Note: do NOT submit product labels or literature.) Special instructions:

4. Send Certificate To
Other, describe:

1 above

2 above

Send Invoice To

1 above

2 above

Company name

Address

Contact person name, phone, email City State ZIP code

5. Certificate Delivery
Certificates will be mailed via the U.S. Postal Service (regular mail) unless you make special arrangements as follows: Carrier name (express mail) Your account number

6. Fees $10 for each certificate. Do not send money. You will receive an invoice. 7. Signature "The requester hereby presents and acknowledges that the company is aware that in making this request the company is subject to the terms and provisions of Title 18, Section 1001, United States Code which makes it a criminal offense to falsify, conceal, or cover up a material fact; make any material false, fictitious, or fraudulent statement or representation; or make or use any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry."
Signature Name and Title Date

FORM FDA 3613d (2/06)

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Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition

OFFICE OF COSMETICS AND COLORS "CERTIFICATE" (EXPORTS) APPLICATION Instructions
1. Requester Information
The company or person requesting the certificate. GENERAL certificate: A General 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 fill in the quantity of certificates you require. You need not submit any other information. PRODUCT SPECIFIC certificate: A Product Specific certificate states that FDA has on file a letter regarding specific product(s), which will be listed by name in an attached Product List. 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 if 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) by exact brand name as they appear on the cosmetic product label (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. Mail your Certificate request 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

2. Exporting Company Information
The company or person whose name and address will appear on the "To Whom It May Concern" letter (attached to each certificate). No name or address is listed on the actual certificate. NOTE: Do not request a cosmetic certificate for a product classified as a drug in the United States. The terms "drug" and "cosmetic" are defined in the Federal Food, Drug, and Cosmetic Act (Sections 201 (g) and (i)). · The term "drug'' means articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, and articles (other than foods and dietary supplements) intended to affect the structure or any function of the body of man or other animals. · The term "cosmetic'' means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap (soap is defined in the Code of Federal Regulations at 21 CFR 701.20).

3. Type of Certificate Requested
FDA issues two types of certificates for cosmetics: 1. General and 2. Product Specific. You will need to determine from the importing country which type will be accepted. The certificates are described as follows:

Paperwork Reduction Act Statement Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the address below. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Cosmetics and Colors, HFS-125, CPK2 5100 Paint Branch Parkway College Park, MD 20740-3835 An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
FORM FDA 3613d (2/06) Page 2 of 2