Form FDA Form 3613d FDA Form 3613d OFFICE OF COSMETICS AND COLORS “CERTIFICATE” (EXPORTS) A

Form Approved: OMB No. 0910-0498; Expiration Date: 3/31/2015

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

Date

1. Requester Information
Company name

Address

Contact person name
Contact phone

City

Contact fax

State

Contact email

Country

ZIP/postal code

2. Exporting Company Information (the name and address to appear on the certificate)
Company name

Address

Contact person name
Contact phone

City

Contact fax

State

Contact email

Country

ZIP/postal code

3. Type of “Certificate” Requested
GENERAL

Quantity:

(Note: no specific products will be listed.)

You must type a “PRODUCT LIST” for each certificate requested. This
PRODUCT SPECIFIC Quantity:
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

1 above

Send Invoice To

2 above

1 above

2 above

Other, describe:
Company name

Contact person name, phone, email

Address

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
materially false, fictitious, or fraudulent statement or representation; or make or use any false writing or document knowing the same to contain any
material false, fictitious, or fraudulent statement or entry.”
Signature

FORM FDA 3613d (3/12)

Name and Title

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Date

PSC Publishing Services (301) 443-6740

EF

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.

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).

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:

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:

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 1 hour per response, including the time to review
instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of
information. Send comments regarding this burden estimate or any other aspect of this information collection, including
suggestions for reducing this burden, to:
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a person is not required to respond to, a
collection of information unless it displays a
currently valid OMB control number."

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
1350 Piccard Drive, Room 400
Rockville, MD 20850
FORM FDA 3613d (3/12)

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