FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Office of Cosmetics and Colors
June 6, 2000; revised May 4, 2005 and December 1, 2005


Voluntary Cosmetic Registration Program (VCRP)


How to
Participate


  1. 1) Registering cosmetic manufacturing establishments. Cosmetic manufacturers or packers whose products are in commercial distribution in the United States should register their establishments, using a separate Form FDA 2511 for each manufacturing location. Only manufacturers and packers should register, not distributors. FDA assigns a registration number to each manufacturing establishment registered and sends you a receipt.
  2. 2) Filing Cosmetic Product Ingredient Statements (CPIS). A cosmetic manufacturer, packer, or distributor should file a statement for each product the firm has entered into commercial distribution in the United States. With the distributor's permission, a private labeler or packer also may file these forms. Use a separate Form FDA 2512 for each formulation. (If you are using printed forms, you will need both FDA Form 2512 and 2512a.) You also may file a CPIS to amend an earlier submission if you change the formulation.
    • Discontinuing a Product Formulation: CPIS numbers do not have an expiration date, so it is important for you to follow the procedures in 21 CFR 720.6 to amend a filed formulation or to discontinue a filed product that is no longer in commercial distribution. If you are filing via Internet, use Form 2512 to discontinue a CPIS. If you are using paper forms, use Form 2512, Form 2514 or your company's letterhead

About VCRP

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States. There are two parts to the VCRP, described in detail in the sections below. You may participate in both parts of the program or only one part. No fees are required to participate in this voluntary program.

The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. It also does not apply to hotel samples or free gifts or cosmetic products you make in your home to sell to your friends.

Benefits of VCRP participation

The VCRP helps FDA in its mission to protect consumers, while also helping cosmetic manufacturers and distributors make informed decisions. The greater the participation by the cosmetic industry, the better this program works.

While voluntary registration and assignment of a registration number do not denote approval of a firm or its products, the following are some of the ways in which you may benefit directly through your participation.

Participating in the VCRP puts manufacturers in the pipeline for important information about cosmetic ingredients. The information received by FDA from the VCRP is entered into a computer database. If it is determined that a cosmetic ingredient presently being used is harmful and should be removed from product use, FDA can notify the manufacturers and distributors of affected products by using a mailing list (or email list if you participate via Internet) generated from the VCRP database. If your products are not in the registration database, you won't be on the notification mailing list.

The VCRP supports the safety evaluation of cosmetic ingredients. Information from the VCRP database assists the Cosmetic Ingredient Review (CIR) Expert Panel in determining its priorities for ingredient safety review. (The CIR is an independent, industry-funded panel of scientific experts that regularly assesses the safety of numerous cosmetic ingredients and publishes its findings. FDA representatives attend CIR meetings in a non-voting capacity.)

Some things you should know


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