FDA registration for cosmetics is voluntary. Manufacturers are not required to register their facilities nor their products with FDA. The FDA voluntary cosmetic registration program is a Reporting System created by the FDA for manufacturers, packers, and distributors of cosmetic products within the United States. There are two components to the program; (1) registration of the facility; and (2) listing of cosmetic ingredients. FDA uses the database of information as a means of monitoring the Cosmetic industry.
The information provided by the voluntary registration allows FDA to know the current ingredients being used in cosmetic products, the frequency of their use, the types of cosmetic products on the market, and the companies who are manufacturing these products. The database has been used by the Cosmetic Ingredient Review (CIR), an independent, industry-funded panel of scientific experts, to assist the CIR Expert Panel in assessing ingredient safety and determining priorities for ingredient safety review.
First, the facilities that can be registered are manufacturers and packers. Locations that only conduct sales or administrative functions, but do not house products can not register. Distributors also can not register their facilities. Registration can occur before or after putting a cosmetic product into the US market. Once the cosmetic FDA registration is complete FDA will assign a facility registration number to the registered location. In the event a company has more than two locations each location will have a registration number.
Electronically submit FDA Form 2512 for each cosmetic formulation. FDA will then issue a Cosmetic Product Ingredient Statement Number for each formulation filed.
FDA allows for an amendment to the formulations submitted through its voluntary FDA registration program. In addition, a formulation can be updated to show its discontinued use in the market.