VCRP: Paper Submissions

Participating in the Voluntary Cosmetic Registration Program (VCRP) Using Printed Forms

FDA's Office of Cosmetics and Colors has developed an online registration system, intended to make it easier to participate in the VCRP. You may still use paper forms, following the instructions listed on the left. However, we currently are experiencing significant delays processing paper VCRP forms in a timely manner because of resource constraints. We strongly encourage you to participate in the VCRP using the online program.

If you do choose to file printed forms, please read the instructions - both the introduction and the instructions for each individual form - completely before you attempt to fill out these forms.

These instructions are designed to guide you step by step through the registration process. Thank you.

Introduction: General Information on Filing Your VCRP Forms

This introduction provides general information on using the following forms:
Forms FDA 2512 and 2512a - Cosmetic Product Ingredient Statement (CPIS), and
Form FDA 2514 - Discontinuance of Commercial Distribution of Cosmetic Product

Forms FDA 2512, 2512a, and 2514: What each form is for

Forms FDA 2512 and 2512a go together. Use Form FDA 2512 for listing your brand names. Use Form FDA 2512a for listing specific ingredients.

Use Form FDA 2514 to notify FDA that you are discontinuing a formulation.

(You also may use the VCRP to register your establishment using Form FDA 2511. Instructions for filing Form FDA 2511 appear on the back of preprinted forms and accompany forms downloaded from the FDA Web site.)

Who should file original CPIS Forms FDA 2512 and 2512a, and when

Any firm, whether domestic or foreign, that manufactures or distributes cosmetics in the United States may file Forms FDA 2512 and 2512a. Additionally, a private labeler or packer of a cosmetic may file these forms.

You should file these forms within 60 days from the date of commercial distribution of the cosmetic product in the United States.

Who should file amendments to CPIS Forms FDA 2512 and 2512a, and when

Any firm, once having filed a CPIS form, is responsible for maintaining an accurate filing with FDA for that product.

Please notify FDA of changes in a brand name or ingredients within 60 days from an amended product's commercial distribution. Please submit other amendments within one year.

Who should file discontinuance Form FDA 2514, and when

A firm, once having filed a CPIS form, should notify FDA when the cosmetic formulation is no longer in commercial distribution.

You should notify FDA within 180 days after a product has been removed from commercial distribution.

How to obtain forms

You may obtain printed forms from your nearest FDA District Office or by contacting the Office of Cosmetics and Colors at (240) 402-1257. You also may download forms from the FDA Web site.

How to request confidentiality

Information voluntarily disclosed to FDA is available to the public unless:

1. The person submitting it -
   1. requests exemption from public disclosure and
   2. provides documentation showing that the information is a trade secret, or is commercial or financial information that is privileged or confidential, and
2. FDA accepts the information in confidence upon review of the submitted factual data.

If you consider the identity of an ingredient confidential, you must follow these steps:

• Attach to the submission, in triplicate, a statement of the factual and legal grounds supporting the request for confidentiality. Title 21 of the Code of Federal Regulations, Part 720.8 (21 CFR 720.8), Confidentiality of Statements, discusses how to prepare a Request for Confidentiality).
• Submit your forms for presubmission review for confidentiality.
• Request that FDA return your submission if your request for confidentiality is denied.
• Mark the appropriate block on Form FDA 2512a, as noted in the Form FDA 2512a instructions.

If you do not request confidentiality, the information becomes the property of FDA. For complete information on confidentiality of registration information, please refer to Title 21 of the Code of Federal Regulations, Part 720.8 (21 CFR 720.8).

Cosmetic Product Ingredient Statement (CPIS) Numbers - Use and restrictions

After receiving and accepting CPIS Forms FDA 2512 and 2512a for a product, FDA will assign the product a CPIS number. CPIS numbers are intended only for use in the VCRP. Assignment of a CPIS number does not in any way denote FDA approval of the firm or its product. Any representation in labeling, advertising, or trade literature that creates an impression of such official approval is considered misleading (21 CFR 720.9).

Special notes on preparing your forms

Type entries in CAPITAL LETTERS, starting at the extreme left of each space provided.

Use standard abbreviations whenever possible.

Omit all punctuation except in chemical names.

FDA does not expect the typing of forms to be perfect. You will note that several of the "Sample Submissions" contain "typing errors" that have simply been "XXXXed" or "----- ed" out. We have tried to leave room in each block for typing errors to be crossed out and retyped. If you find there is no room in a brand name block or ingredient block for the information to be corrected, "XXXX" out the block and use the next available block. Pen corrections are also acceptable if they are legible.

Sign and date the completed forms. FDA cannot accept unsigned forms and will return them unprocessed.

Mailing the completed forms

If your are using preprinted forms mailed to you by FDA, remove the REGISTRANT'S COPY from each completed form and retain it for your records. Do not separate the remaining two parts. If you have printed forms from FDA's Web site, make two copies of each completed form. Keep one copy for your records. Mail the original and one copy to FDA.

Staple together Form FDA 2512 and one or more Forms FDA 2512a pertaining to the same CPIS; attach, where appropriate, the supporting statement for confidentiality; and send them to:

Voluntary Cosmetics Registration Program
HFS-125
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835

How FDA will acknowledge receipt and acceptance of your forms

FDA will acknowledge its receipt and acceptance of the forms you have filed by returning the OFFICIAL RECEIPT to you after FDA personnel have finished reviewing them. The OFFICIAL RECEIPT is located at the bottom of Form 2512. If you print forms from FDA's Web site, the receipt will print out as a page of Form 2512.

If your submission is complete, FDA will return the OFFICIAL RECEIPT to you marked COMPLETE, listing the Cosmetic Product Ingredient Statement Number (CPIS NO.) assigned to the submission.

If your submission is incomplete, FDA will return the forms to you, along with a request for the additional information needed to complete the submission. After FDA receives the requested information, FDA will send you the OFFICIAL RECEIPT marked COMPLETE, listing the CPIS NO.