Now that we have entered the first year post cosmetic registration and listing requirements, it’s a good time to review your records and make sure you are prepared for your update / renewal process. For facility registrations, an update should be submitted within 60 days of any changes to the information required for the registration (see section C.1 of the Guidance for Industry). The biennial renewal submission must align with your initial facility registration (renewal must be submitted in the same month your initial registration was submitted, 2 years after first registering). Do note, this is the only registration renewal process that falls outside the Oct-Dec renewal period. Your records will dictate when to submit your biennial renewal. For a cosmetic product listing, updates should be submitted annually. Important to remember with a cosmetic product listing, the following fields cannot be updated in a listing file: Product name; Ingredients (including fragrance, color, and flavor); Product categories and Responsible person. If changes are needed to any of these noted fields the original cosmetic listing must be discontinued and a new product listing must be submitted. The required cosmetic product listing annual renewal has an abbreviated process for any cosmetic listing that has had no change to the required information. If a product has been discontinued, that would be considered a required annual update, and the listing should be submitted to reflect this status.
If you need support with this process, please reach out to Victoria Pankovich.
Posted in Cosmetics, FDA and USDA Regulatory Update.