In more detail
At present, the cosmetic products for which the refill stations may be used under these notifications are limited to liquid perfumes and rinsed-off liquid body and/or hair/scalp cleansing products (which have been notified to the FDA). The setting up of the refill stations must follow the criteria and conditions prescribed in these notifications (e.g., training of personnel, premises, tools and equipment, safety control, packaging and labeling). Manufacturers or importers who would like to set up refill stations must obtain pre-approval from the FDA. Furthermore, bulk cosmetics and refill cosmetics must have labels with specific information and must follow the current cosmetic labeling regulations.
The FDA is also in the process of finalizing the draft regulation on refill stations for hazardous substance type I in liquid form, which are household cleaning products for floors, walls, sanitary wares and other materials containing prescribed substances controlled by the FDA. The criteria and conditions are similar to the requirements for cosmetic refill stations. We understand that this regulation will be issued later this year.
For more information, please contact our Healthcare & Life Sciences Industry Group and Regulatory Affairs Services Department at Baker McKenzie.