The new fragrance allergen labeling requirements under the EU Cosmetic Products Regulation are set to significantly impact the cosmetics industry, requiring many products to be reformulated or relabeled.
In this webinar, we’ll break down what these changes mean for your business. Our experts will explain which products must be evaluated, identify the ingredients most likely to contain regulated allergens, and unpack the complexities of the updated requirements.
We’ll also explore key compliance timelines and how these changes may directly affect your supply chain, helping you prepare and avoid potential disruptions.
Speaker:
Jaclyn Bellomo brings over 15 years of experience in technical formulation, regulatory compliance, product development, and quality management. With a strong background working with multinational brands, she specializes in beauty and personal care formulations from concept to commercialization. Jaclyn is an active member of several industry committees focused on cosmetic compliance and education, and holds a B.S. in Chemistry, along with M.S. degrees in Cosmetic Science, Regulatory Affairs, and Business Administration.
For Medical Device Establishments, who must register?
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
What information is submitted for medical device establishment registration?
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.
