CFSAN/Office of Cosmetics and Colors
June 6, 2000; revised May 4, 2005 and December 1, 2005
Voluntary Cosmetic Registration Program (VCRP)
- 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) 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
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
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
- Know the legal difference between cosmetics and drugs. Some cosmetic products may also be drugs.
Additional information on these types of products is available elsewhere on FDA's Web site.
For example, you may wish to refer to "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)."
- The VCRP is not a cosmetic approval program. Cosmetics are not subject to FDA premarket approval or
mandatory establishment registration or ingredient reporting. It is the firm's responsibility to assure that
its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law. Assignment
of a number by FDA to a cosmetic establishment or a cosmetic product does not in any way denote approval of the
establishment or its products and does not constitute an admission, or agreement, or determination by FDA that
a product is a cosmetic as defined in section 201(i) of the
Federal Food, Drug, and Cosmetic Act.
- The VCRP is not part of an import notification system. Firms importing products considered to be solely
cosmetics in the United States are not required to register with FDA, and a registration number is not required
for importing cosmetics into the United States.
- The VCRP is not a promotional tool. It is prohibited to use VCRP participation or an assigned registration or
filing number for promotional purposes (see 21 CFR, parts 710.8 and 720.9).
- Certain information from the VCRP database is available through the Freedom of
Information Act (FOIA). For example, FDA sometimes receives such requests from consumers or healthcare
providers who wish to identify products that do or do not contain certain ingredients. Proprietary business
information is not releasable under FOIA. Firms may submit written requests for confidentiality of a cosmetic
ingredient in accordance with the regulation at 21 CFR 720.8, which also states how
FDA handles such requests.
- The regulations authorizing this program are found in Title 21 of the Code of
Federal Regulations (21 CFR), parts 710 and 720.