Voluntary Cosmetic Registration Program

Voluntary Cosmetic Registration Program

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Voluntary Cosmetic Registration Program (VCRP)

If you are in the cosmetic industry, you know how important it is to comply with international regulations and ensure the safety of your products. Voluntary cosmetic registration programs can help you achieve these goals and gain a competitive edge in the market. This web page provides comprehensive information on the benefits of voluntary cosmetic registration programs. You will learn about the regulatory requirements for registering your cosmetic products, as well as the advantages of doing so. From enhancing product safety to improving your brand reputation, voluntary cosmetic registration programs can have a significant impact on your business. We also provide guidance on how to navigate the registration process, including the documents you will need to submit and the fees associated with registration.

The Federal Food, Drug, and Cosmetic (FD&C) Act does not require cosmetic firms to register their establishments or list their product formulations with FDA. 

FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with Voluntary Cosmetic Registration Program (VCRP), but as its name indicates, participation in this program is voluntary, not mandatory.

VCRP applies only to cosmetic products being sold to consumers in the United States

The program is only applicable to products sold to consumers and not for professional products, such as products used in beauty salons, spas, or skin care clinics. It also does not apply to products that are not for sale, such as hotel samples, free gifts, or cosmetic products you make in your home to give to your friends.

VCRP is not a cosmetic approval program or a promotional tool

Registration of a cosmetic establishment, assignment of an establishment registration number, or filing a cosmetic product does not mean that FDA has approved the firm or its products or that a product is a cosmetic as defined in the FD&C Act.

Any representation in labeling or advertising that creates an impression of official approval because of registration or possession of a registration number is considered misleading. Misleading labeling makes a cosmetic misbranded.

In-Depth Coverage: Importing Cosmetics

In-Depth Coverage: Marketing and Advertising Compliance

How to Participate in VCRP

There are two components to the program, and participant involvement can be in one or both components. The first component (21 CFR 710) outlines the requirements for the voluntary establishment registration portion of the program. Owners or operators of facilities where cosmetics are manufactured and/or packaged can register their establishments. The FDA will assign a registration number to each establishment location.

The second component (21 CFR 720) outlines the requirements for the voluntary qualitative cosmetic product ingredient composition statements portion of the program. On the product label, these ingredients will be listed in descending order of predominance.

A cosmetic manufacturer, packer, or distributor can file a statement for each product the firm has entered into commercial distribution in the United States. The FDA will assign a Cosmetic Product Ingredient Statement Number (CPIS NO.) to each formulation filed in the VCRP.

Registering cosmetic manufacturing and/or packaging establishments

  • Cosmetic establishments are facilities where cosmetics are manufactured and/or packaged, not locations that house only business operations.
  • Only owners or operators of cosmetic manufacturing or packing facilities can register their establishments, using a separate Form FDA 2511 for each facility location.
  • Distributors cannot register an establishment.
  • Domestic firms that have begun operations can register their establishments before or after their products are entered into commercial distribution and for sale to U.S. consumers.
  • Foreign firms may voluntarily register their establishments after their products are exported for sale in the U.S. FDA assigns a registration number to each establishment location.

Filing Cosmetic Product Ingredient Statements (CPIS)

A cosmetic manufacturer, packer, or distributor can file a statement for each product the firm has entered into commercial distribution in the United States.

  • Use a separate Form FDA 2512 for each formulation. (If you are using printed forms, you will need both Form FDA 2512 and 2512a.)
  • FDA assigns a CPIS number to each formulation filed in the VCRP.

Amending or Discontinuing a Product Formulation

  • A CPIS can be amended or discontinued by filing Form FDA 2512 and continuation Form FDA 2512a.
  • Changes to a brand name or ingredients should be submitted within 60 days after the product enters commercial distribution.
  • A CPIS should be discontinued within 180 days after discontinuance of commercial distribution becomes known to you.

Availability and Confidentiality of the VCRP Data

The VCRP database is not publicly available; however, FDA will provide some information, based upon the Freedom of Information Act (FOIA) requests. For example, the 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, however, will not be released pursuant to an FOIA request. Firms may submit written requests for confidentiality of a cosmetic ingredient, which also states how the FDA handles such requests.

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Taking steps to ensure compliance is very important in order to avoid potential problems during the clearance process. The Customs binding ruling program enables importers to receive a binding ruling from CBP on the treatment of your goods when entering the U.S. 

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An ISF is required when cargo (ocean only) laden on vessel at a foreign port is destined for shipment to the U.S.  Under ISF rule, some importing information and details regarding cargo must be transmitted to the CBP at least 24 hours before goods are loaded onto the vessel.

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If you want to sell your products in U.S. marketplaces, but you are a business owner located outside of the U.S., and do not have an entity or physical presence in the U.S., you need to be established as a Foreign Importer of Record before your goods can be imported into the U.S. We can help you. 

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