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5. August 2024- Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
- Product Listing: A “responsible person” (the manufacturer, packer, or distributor) must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
- Adverse Event Reporting: A responsible person is required to report serious adverse events (such as hospitalization) associated with the use of cosmetic products in the United States to the FDA within 15 business days
- Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products.
The requirements will apply to the following cosmetics categories:
- Baby products, including shampoo, lotion, oil, creams, and Babytücher
- Bath products, including bubble bath, bath oils, tablets, and salts, bath wipes
- Eye makeup, including eyebrow pencils, eye shadow, and mascara. Make-up-Entferner-Tücher
- Childrens’ eye makeup
- Fragrances, including perfume and cologne
- Hair preparations, including conditioner, hair spray, and shampoo
- Hair coloring preparations, including hair dye, tints, and coloring rinses
- Non-eye makeup, including blush and rouge, face powder, foundation, and lipstick
- Children’s makeup (non-eye), including face paint and lip gloss
- Manikürepräparate, einschließlich Nagellack, Nagelverlängerungsmittel und Nagelhautweichmacher
- Orale Produkte, einschließlich Mundwasser und Zahnpasta
- Persönliche Reinigungsprodukte, einschließlich Deodorant, Seife und Körperwaschmittel
- Rasierpräparate, einschließlich Rasiercreme und Aftershave
- Hautpflegepräparate, einschließlich Cremes, Lotionen, Puder und Sprays
- Sonnencremes, Cremes, Gele usw.
- Tätowierungspräparate, einschließlich permanente und temporäre Tätowierungstinte
The FDA hosted a webinar that provided an overview of the Modernization of Cosmetics Regulation Act of 2022, detailing the requirements mandated by the act and the current steps the FDA is taking to implement these requirements. The webinar also included an update on the Voluntary Cosmetic Reporting Program and information about an upcoming public listening session on good manufacturing practices (GMPs).




