The Voluntary Cosmetic Registration Program (VCRP) is a reporting system that can be used by manufacturers, distributors, or packers to register their cosmetic products for commercial distribution in the US market. As the name itself suggests, VCRP is a voluntary program and even when it is not a mandatory requirement as per the US FDA regulations, it is the responsibility of the manufacturer or brand owner to ensure the safety of their cosmetic product.
Once the sale hits an annual gross of $1000, the manufacturer, distributor, or packer who placed the given cosmetic product(s) in the US market for commercial sale is eligible to file the VCRP. It should be noted that one cannot file VCRP forms prior to placement of products in the market. Also, VCRP does not apply to cosmetics for professional use only and to cosmetics that are not for sale.
There are two forms in the VCRP filing process.
Form 2511: Registering cosmetic manufacturing and/or packaging establishment. This form can be used only by manufacturers or packers to register their establishments.
Form 2512: Filing Cosmetic Product Ingredient Statements (CPIS). This form can be used by manufacturers, distributors, or packers to file the cosmetic product formulation.
Any person who intends to file a VCRP form must request the US FDA for a VCRP account. Upon requisition, the US FDA reviews and provides a VCRP account along with a temporary password to access the account within 21 days.
Once the account is approved, one can file for either Form 2511 or Form 2512 or both. In case of discontinuation or amendment in the cosmetic product formulation, an amendment can be submitted to the US FDA by filing Form 2512a. Also, one must submit a separate Form 2152 for each formulation.
Would you be interested to understand the VCRP registration process in a more detailed manner? Athreva’s team of cosmetic industry experts will help you sail through a diverse range of voluntary and mandatory Cosmetic regulatory requirements to ensure that your product is safe and compliant as per the US FDA.
The author of this blog Dr. Sravya is one of our in-house cosmetic regulatory experts. With hands-on experience in consulting for cosmetic manufacturing companies worldwide, her sharp eye for detail speaks for itself. You can find her on Linkedin.
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