July 31, 2021
US FDA’s Voluntary Cosmetic Registration Program (VCRP) and Prerequisites

Voluntary Cosmetic Registration Program (VCRP) is a reporting system that is used by cosmetics manufacturers and distributors within the US. The VCRP provides information to the FDA about cosmetic products marketed in the United States, such as frequency of use, commercial commitment, etc. The VCRP is essential for all cosmetic manufacturers or distributors as it provides comprehensive ingredient information to the Cosmetic Ingredient Review (CIR), that helps in assessing the safety of ingredients used in the product formulation. Here we list out a few things which may help a cosmetic manufacturer or distributor to understand the VCRP.

How does the VCRP Works?

There exists two (02) important Forms in the VCRP filing process:

  • Form 2511 is for registering cosmetic manufacturing/packaging facilities. This form can be used only by cosmetic manufacturers or packers to register their facilities.
  • Form 2512 is for filing (CPIS) Cosmetic Product Ingredient Statements. This form can be used by manufacturers, packers or distributors to file the cosmetic product formulation.
  • You can either chose to take in both parts of the program or just one. The Voluntary Cosmetic Registration Program guidelines can be found in 21 CFR, parts 710 and 720.

Requirements to File Both the Forms

  • Name and address of the manufacturer, packer or distributor
  • Annual gross sale of $1,000 worth of cosmetics
  • Comprehensive list of ingredients in the formulation
  • Labels that are compliant with the US FDA labeling regulations
  • Brand name of the product and product use/function
  • E-commerce website URL where US consumers can acquire more information about the product and can also purchase the same

How to Register for VCRP?

  • Anyone wishing to register for a VCRP form must first obtain a VCRP account with the US FDA. The US FDA evaluates the cosmetics and issues a VCRP account with a temporary password that must be used within 21 days.
  • After the account has been approved, you can file Form 2511, Form 2512, or both.
  • If a cosmetic product's formulation is changed or discontinued, an amendment is to be submitted to the US FDA by filing Form 2512a along with a separate Form 2512 for each formulation.

Important Things to Know

  • VCRP is a voluntary registration system for cosmetic products as defined by the FD&C Act, section 201(i).
  • Depending on the product claims, some cosmetics can also be classified as drugs. If a product is also classified as a drug, then it must comply with the regulations for both drugs and cosmetics.
  • The VCRP is not considered a cosmetic approval program or a promotional tool. Cosmetics are all subject to the FDA’s premarket approval. It is the manufacturer’s responsibility to validate that the product and ingredients are safe, correctly labeled and comply with all the regulations.
  • Voluntary Cosmetic Registration Program is not considered to be a part of a prior notice system for imported cosmetic products. Manufacturers importing cosmetics are only classified as cosmetics and are not required to register with the FDA.

Benefits of VCRP

  • Provides FDA information on all the cosmetic ingredients.
  • Assists FDA to identify and notify the manufacturers and distributors of the affected products.

VCRP assists the FDA with monitoring every cosmetic product which is to be sold solely in the US. Would you like to place your cosmetic product in the US market? Decode more information about the VCRP. Reach out to a proven Regulatory expert.