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Cosmetics are not subject to FDA pre-approval or mandatory establishment registration or ingredient reporting. However, FDA's Office of Cosmetics and Colors (OCAC) maintains the Voluntary Cosmetic Registration Program (VCRP), which was established at the request of the cosmetic industry. The VCRP helps FDA in its mission to protect consumers, while also helping cosmetic manufacturers and distributors make informed decisions.
The program consists of two parts: The voluntary registration of cosmetic manufacturing establishments and the voluntary filing of cosmetic product ingredient statements (formulations). The regulations authorizing this program are found in Title 21 of the Code of Federal Regulations (CFR), parts 710 and 720.
The greater the participation by the cosmetic industry, the better this program works. Although voluntary registration and assignment of a registration number do not denote approval of a firm or its products and it is prohibited to use VCRP participation or an assigned registration or listing number for promotional use (see Title 21 of the CFR, parts 710.8 and 720.9), 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 data base. If it is determined that a cosmetic ingredient presently being used is harmful and should be removed from product use, FDA can notify the product's manufacturer or distributor by using a mailing list generated from the VCRP database. If your products are not in the registration database, you won't be on the notification mailing list.
Participating in the VCRP helps avoid problem ingredients before they result in product recalls or import detentions. If a cosmetic manufacturer files a product formulation with the VCRP, FDA can advise the manufacturer if he or she is inadvertently using a non-permitted color additive or other prohibited or restricted ingredients. In this way, manufacturers can correct their formulations before attempting to import or distribute them, thus avoiding the risk of a recall or detention due to ingredient-related violations.
The VCRP helps retailers identify safety-minded manufacturers. Retailers, such as department stores, sometimes contact FDA to learn whether a cosmetic company is registered with the agency. Although registration does not denote FDA approval, it does indicate that your products have been reviewed by FDA and entered into the Agency's database. If you submit a product formulation that appears to be incomplete, or that contains a prohibited ingredient or an unapproved color additive, you will be notified by FDA.
Registering cosmetic manufacturing establishments. Cosmetic manufacturers or packers 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.
Filing Cosmetic Product Ingredient Statements (CPIS). The cosmetic manufacturer, packer, or distributor should file a statement for each product the firm markets. With the distributor's permission, a private labeler or packer also may file these forms. The CPIS consists of two parts. The first part, FDA Form 2512, lists products. The second part, FDA Form 2512a, lists individual ingredients. FDA assigns a registration number to each formulation registered and sends you a receipt.
You also may use forms 2512 and 2512a to amend an earlier submission if you change the formulation. Use FDA Form 2514 to let FDA know you have discontinued a product.
Instructions are available online at http://www.cfsan.fda.gov/~dms/cos-reg2.html.
Forms are available online in PDF format: (Help for PDFs)
To receive forms and instructions by mail, you may contact OCAC at (202) 418-3414. You also may fax a request for forms and instructions to OCAC at (202) 208-6937, or mail your request to:
Voluntary Cosmetics Registration Program
HFS-125
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
You also may request forms from your nearest FDA district office.
